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Sample records for cats fda perspective

  1. Biosimilars: the need, the challenge, the future: the FDA perspective.

    Science.gov (United States)

    Epstein, Michael S; Ehrenpreis, Eli D; Kulkarni, Prasad M

    2014-12-01

    This article summarizes the brief history of the biosimilars industry, the FDA's regulations and guidance for biosimilars development, and the issues and challenges facing developers and regulators in bringing biosimilars to market. Current literature, regulations, and FDA guidance documents were summarized and interpreted to define biosimilars and to present their financial and clinical implications. Some biologic agents that will lose patent protection during the next few years may be replaced with lower cost follow-on biologics. However, unlike generic drugs, biosimilars may be structurally and functionally different from the reference product they are designed to resemble. The FDA has yet to approve any agent via the abbreviated licensure pathway for biosimilars that was passed as part of the Affordable Care Act. The FDA has issued new guidance describing processes by which manufacturers may demonstrate either biosimilarity or interchangeability with an FDA-approved biologic agent, which is required for abbreviated licensure. Biosimilars approved in Europe consist of relatively small molecules; complex large-molecule biosimilars could be subjected to a rigorous and prolonged FDA approval process, which would defeat attempts to develop lower-cost versions of biologic drugs. Biosimilar development is a consequence of the financial success of biologic therapies and their eventual patent expiration. The pharmaceutical industry must now develop complex biosimilars that resemble FDA-approved biologic agents and invent analytical tools and end points to demonstrate similarity to regulatory authorities. Already in development is a new wave of "biobetter" or "biosuperior" drugs that mimic but also improve upon a biologic drug's chemistry, formulation, or delivery.

  2. FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access.

    Science.gov (United States)

    Hurst, Frank P; Lee, Robert E; Thompson, Aliza M; Pullin, Brian D; Silverstein, Douglas M

    2018-03-07

    In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative's mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area. Copyright © 2018 by the American Society of Nephrology.

  3. The Pharmaceutical Industry in 2017. An Analysis of FDA Drug Approvals from the Perspective of Molecules.

    Science.gov (United States)

    de la Torre, Beatriz G; Albericio, Fernando

    2018-02-27

    This is an analysis from a chemical point of view of the 46 drugs (34 New Chemical Entities and 12 Biologics) approved by the FDA during 2017. The drugs included in the 2017 "harvest" have been classified on the basis of their chemical structure: biologics (antibodies and proteins); peptides; amino acids and natural products; drug combinations; and small molecules.

  4. FDA Warns About Stem Cell Therapies

    Science.gov (United States)

    ... the FDA published a perspective article in the New England Journal of Medicine . The FDA will continue to help with the development and licensing of new stem cell therapies where the scientific evidence supports ...

  5. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  6. Measuring general surgery residents' communication skills from the patient's perspective using the Communication Assessment Tool (CAT).

    Science.gov (United States)

    Stausmire, Julie M; Cashen, Constance P; Myerholtz, Linda; Buderer, Nancy

    2015-01-01

    The Communication Assessment Tool (CAT) has been used and validated to assess Family and Emergency Medicine resident communication skills from the patient's perspective. However, it has not been previously reported as an outcome measure for general surgery residents. The purpose of this study is to establish initial benchmarking data for the use of the CAT as an evaluation tool in an osteopathic general surgery residency program. Results are analyzed quarterly and used by the program director to provide meaningful feedback and targeted goal setting for residents to demonstrate progressive achievement of interpersonal and communication skills with patients. The 14-item paper version of the CAT (developed by Makoul et al. for residency programs) asks patients to anonymously rate surgery residents on discrete communication skills using a 5-point rating scale immediately after the clinical encounter. Results are reported as the percentage of items rated as "excellent" (5) by the patient. The setting is a hospital-affiliated ambulatory urban surgery office staffed by the residency program. Participants are representative of adult patients of both sexes across all ages with diverse ethnic backgrounds. They include preoperative and postoperative patients, as well as those needing diagnostic testing and follow-up. Data have been collected on 17 general surgery residents from a single residency program representing 5 postgraduate year levels and 448 patient encounters since March 2012. The reliability (Cronbach α) of the tool for surgery residents was 0.98. The overall mean percentage of items rated as excellent was 70% (standard deviations = 42%), with a median of 100%. The CAT is a useful tool for measuring 1 facet of resident communication skills-the patient's perception of the physician-patient encounter. The tool provides a unique and personalized outcome measure for identifying communication strengths and improvement opportunities, allowing residents to receive

  7. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  8. FDA Acronyms and Abbreviations

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

  9. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

    Science.gov (United States)

    Khin, N A; Yang, P; Hung, H M J; Maung-U, K; Chen, Y-F; Meeker-O'Connell, A; Okwesili, P; Yasuda, S U; Ball, L K; Huang, S-M; O'Neill, R T; Temple, R

    2013-08-01

    Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

  10. FDA Drug Label Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...

  11. FDA Recognized Consensus Standards

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...

  12. Changing perspectives on aging and energy requirements: aging and energy intakes in humans, dogs and cats.

    Science.gov (United States)

    Harper, E J

    1998-12-01

    A series of cross-sectional and longitudinal studies conducted in humans has shown that aging is associated with a gradual decline in the maintenance energy requirement. Generally, this is equivalent to a total decrement of 20% of young adult maintenance energy requirements and is a result of a decrease in both physical activity and basal metabolic rate. Relatively few such studies have been conducted in dogs, but the results have been consistent. It appears that maintenance energy requirements decline by approximately 20%, and it is assumed that the causal factors are the same as those for humans. The situation appears to be somewhat different in cats, with evidence to date indicating that maintenance energy requirements remain constant throughout adult life. Why cats should be different from other species is not clear, but it is hypothesized that relative inactivity is typical of most cats' behavior, such that there is no obvious age-related change. In terms of feeding regimens for senior cats and dogs, it is appropriate to decrease energy provision for senior dogs by approximately 20%, whereas the energy provision for senior cats should not be decreased.

  13. FDA Approval for Imiquimod

    Science.gov (United States)

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  14. EVA geen FDA

    NARCIS (Netherlands)

    Folbert, J.P.; Dagevos, J.C.

    2001-01-01

    De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de

  15. A biogeographical population genetics perspective of the colonization of cats in Latin America and temporal genetic changes in Brazilian cat populations

    Directory of Open Access Journals (Sweden)

    Manuel Ruiz-García

    2008-01-01

    Full Text Available We used nine morphological genes to analyze cat populations from Mexico, the Dominican Republic, the Colombian, Brazilian and Peruvian Amazon, Bolivia and Brazil. Most populations were in Hardy-Weinberg equilibrium at the O locus. The highest allele frequencies so far detected at world level for alleles I (inhibitor and L (long hair were found at La Paz (Bolivia. The analyses revealed at least five cat gene pools in Latin America: These findings suggest that the current genetic distribution of cats in Latin America correlates with the colonization of the Americas during the XIV to XVIII centuries. Additionally, the cat populations of São Paulo, Rio de Janeiro and Manaus were sampled, to compare their 1996-2003 genetic profiles with those obtained in 1983. Generally, these genetic profiles seem temporally stable, which is important for comparing cat populations sampled in different years and decades.

  16. Current perspectives on the optimal age to spay/castrate dogs and cats

    OpenAIRE

    Howe, Lisa

    2015-01-01

    Lisa M HoweDepartment of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USAAbstract: Spaying and castrating of dogs and cats has been considered for decades to be a routine standard of practice in veterinary medicine in the US for the prevention of numerous undesirable behaviors, medical conditions, and diseases. Additionally, the procedures have been promoted as a method of curbing the severe pet-over...

  17. Changing perspectives on aging and energy requirements: aging and digestive function in humans, dogs and cats.

    Science.gov (United States)

    Harper, E J

    1998-12-01

    When considering the question of energy balance, it is important to take into account energy provision and the ability of aging animals to digest macronutrients and thus obtain their maintenance energy requirement. A large number of studies have been conducted in humans in an effort to establish whether aging of the gastrointestinal tract has a significant effect on availability of dietary energy. The results of these studies have been conflicting, with indications that some aspects of gut functionality do decline with age, but little evidence overall to suggest that aging humans are at risk of energy deficit due to compromised digestive efficiency. A number of digestibility studies carried out with dogs confirm that there is no evidence of an age-related decline in digestive efficiency. This knowledge makes the determination of energy provision to senior dogs relatively straightforward to calculate. Many senior cats appear to exhibit quite a marked reduction in their ability to digest macronutrients, particularly fat, efficiently. Because this reduces the overall capacity to obtain energy from the diet, it is recommended that old cats should not routinely be offered reduced energy diets. For senior cats, the feeding regimen in later life should be to offer highly digestible diets that provide as much energy as adult maintenance rations.

  18. Is It Really FDA Approved?

    Science.gov (United States)

    ... Preventive Controls for Animal Food rule, a new regulation mandated by the FDA Food Safety Modernization Act (FSMA), requires food companies to take ... is on the market, FDA evaluates the product’s safety through research and ... But FDA regulations require nutrition information to appear on most foods, ...

  19. Current perspectives on the optimal age to spay/castrate dogs and cats

    Directory of Open Access Journals (Sweden)

    Howe LM

    2015-05-01

    Full Text Available Lisa M HoweDepartment of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USAAbstract: Spaying and castrating of dogs and cats has been considered for decades to be a routine standard of practice in veterinary medicine in the US for the prevention of numerous undesirable behaviors, medical conditions, and diseases. Additionally, the procedures have been promoted as a method of curbing the severe pet-overpopulation problem in the US. Recently, however, this routine practice has come under scrutiny and become a very controversial topic. The general wisdom and safety of the procedures have been questioned by those who are concerned that the procedures may have some unintended consequences that are only recently being recognized. The purpose of this paper is to critically examine the scientific literature regarding elective spay/castration procedures and present both risks and benefits of elective gonadectomy. After the literature is examined, it becomes clear that there may not be a single absolute optimal age to spay or castrate all dogs and cats, but that the optimal age may be dependent upon several factors, including species, breed, body size, and breed-specific diseases, among others. Determining the optimal age to perform elective gonadectomy is much clearer in cats, and the literature demonstrates that the procedures can typically be safely performed at any age after 6–8 weeks of age. The optimal age to spay or castrate dogs of certain breeds (rottweiler, golden retriever, Labrador retriever, and vizsla is becoming less clear as studies are being conducted as to the health benefits and risks in those breeds. This review will examine these controversies and make recommendations as to the optimal age to spay/castrate dogs based upon the scientific literature.Keywords: gonadectomy (neuter, ovariohysterectomy (spay, castration, neoplasia, longevity, orthopedic

  20. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

    Science.gov (United States)

    Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

    2015-01-01

    With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

  1. The Human Kinome Targeted by FDA Approved Multi-Target Drugs and Combination Products: A Comparative Study from the Drug-Target Interaction Network Perspective.

    Science.gov (United States)

    Li, Ying Hong; Wang, Pan Pan; Li, Xiao Xu; Yu, Chun Yan; Yang, Hong; Zhou, Jin; Xue, Wei Wei; Tan, Jun; Zhu, Feng

    2016-01-01

    The human kinome is one of the most productive classes of drug target, and there is emerging necessity for treating complex diseases by means of polypharmacology (multi-target drugs and combination products). However, the advantages of the multi-target drugs and the combination products are still under debate. A comparative analysis between FDA approved multi-target drugs and combination products, targeting the human kinome, was conducted by mapping targets onto the phylogenetic tree of the human kinome. The approach of network medicine illustrating the drug-target interactions was applied to identify popular targets of multi-target drugs and combination products. As identified, the multi-target drugs tended to inhibit target pairs in the human kinome, especially the receptor tyrosine kinase family, while the combination products were able to against targets of distant homology relationship. This finding asked for choosing the combination products as a better solution for designing drugs aiming at targets of distant homology relationship. Moreover, sub-networks of drug-target interactions in specific disease were generated, and mechanisms shared by multi-target drugs and combination products were identified. In conclusion, this study performed an analysis between approved multi-target drugs and combination products against the human kinome, which could assist the discovery of next generation polypharmacology.

  2. Development of the FDA Tobacco Credibility Scale (FDA-TCS).

    Science.gov (United States)

    Schmidt, Allison M; Ranney, Leah M; Noar, Seth M; Goldstein, Adam O

    2017-01-01

    Messages from organizations with high, compared to low, credibility may be more persuasive. Whereas the tobacco industry has long recognized the importance of credibility in promoting its messages and public image, the source credibility of key tobacco control organizations has gone largely unmeasured. To assess credibility of a key tobacco regulator, we developed a scale of the US Food and Drug Administration (FDA) tobacco-related credibility. We developed and tested 30 items reflective of the dimensions of source credibility (trust, expertise, and public interest) and FDA's tobacco regulatory roles in a sample of 1353 US adults and assessed reliability and validity. Factor analysis identified 3 dimensions of the FDA Tobacco Credibility Scale (FDA-TCS): public interest, trust, and expertise. The 3 subscales showed evidence of reliability and convergent validity; all subscales were correlated with general FDA credibility and trust in government. Those who knew that the FDA regulates tobacco scored higher on the trust and expertise subscales. The subscales were also associated with support for potential regulations, suggesting criterion-related validity. The FDA-TCS allows for an understanding of the impact of credibility on responses to the FDA's tobacco control communications and regulatory efforts.

  3. The Use of Recombinant Feline Interferon Omega Therapy as an Immune-Modulator in Cats Naturally Infected with Feline Immunodeficiency Virus: New Perspectives.

    Science.gov (United States)

    Leal, Rodolfo Oliveira; Gil, Solange

    2016-10-27

    Type I interferons (IFNs) are well-known cytokines that, among their main functions, are key components of the host immune response against viral infections. Due to its immune modulation properties, they are commonly used in the therapeutic approach of various retroviral infections, namely human immunodeficiency virus (HIV) and feline immunodeficiency virus (FIV). In HIV infection, it has been shown that IFN therapy limits early viral replication, particularly useful on post-exposure prophylaxis. In veterinary medicine, recombinant feline interferon omega (rFeIFN-ω) was the first interferon licensed for use in cats. Several studies have recently shown that this compound seems to stimulate the innate immunity, decreasing clinical signs and co-infections in naturally FIV-infected cats. More than summarizing the main conclusions about rFeIFN-ω in cats, this review emphasizes the immune-modulation properties of IFN therapy, opening new perspectives for its use in retroviral infections. Either in FIV-infected cats or in HIV individuals, type I IFNs seem to induce an innate immune-modulation and should not be overlooked as a therapeutic option in retroviral infections.

  4. The Use of Recombinant Feline Interferon Omega Therapy as an Immune-Modulator in Cats Naturally Infected with Feline Immunodeficiency Virus: New Perspectives

    Directory of Open Access Journals (Sweden)

    Rodolfo Oliveira Leal

    2016-10-01

    Full Text Available Type I interferons (IFNs are well-known cytokines that, among their main functions, are key components of the host immune response against viral infections. Due to its immune modulation properties, they are commonly used in the therapeutic approach of various retroviral infections, namely human immunodeficiency virus (HIV and feline immunodeficiency virus (FIV. In HIV infection, it has been shown that IFN therapy limits early viral replication, particularly useful on post-exposure prophylaxis. In veterinary medicine, recombinant feline interferon omega (rFeIFN-ω was the first interferon licensed for use in cats. Several studies have recently shown that this compound seems to stimulate the innate immunity, decreasing clinical signs and co-infections in naturally FIV-infected cats. More than summarizing the main conclusions about rFeIFN-ω in cats, this review emphasizes the immune-modulation properties of IFN therapy, opening new perspectives for its use in retroviral infections. Either in FIV-infected cats or in HIV individuals, type I IFNs seem to induce an innate immune-modulation and should not be overlooked as a therapeutic option in retroviral infections.

  5. Development of the FDA Tobacco Credibility Scale (FDA-TCS)

    Science.gov (United States)

    Schmidt, Allison M.; Ranney, Leah M.; Noar, Seth M.; Goldstein, Adam O.

    2016-01-01

    Objectives Messages from organizations with high, compared to low, credibility may be more persuasive. Whereas the tobacco industry has long recognized the importance of credibility in promoting its messages and public image, the source credibility of key tobacco control organizations has gone largely unmeasured. To assess credibility of a key tobacco regulator, we developed a scale of the US Food and Drug Administration (FDA) tobacco-related credibility. Methods We developed and tested 30 items reflective of the dimensions of source credibility (trust, expertise, and public interest) and FDA’s tobacco regulatory roles in a sample of 1353 US adults and assessed reliability and validity. Results Factor analysis identified 3 dimensions of the FDA Tobacco Credibility Scale (FDA-TCS): public interest, trust, and expertise. The 3 subscales showed evidence of reliability and convergent validity; all subscales were correlated with general FDA credibility and trust in government. Those who knew that the FDA regulates tobacco scored higher on the trust and expertise subscales. The subscales were also associated with support for potential regulations, suggesting criterion-related validity. Conclusions The FDA-TCS allows for an understanding of the impact of credibility on responses to the FDA’s tobacco control communications and regulatory efforts. PMID:28638857

  6. Schroedinger's cat

    International Nuclear Information System (INIS)

    Lubkin, E.

    1979-01-01

    The issue is to seek quantum interference effects in an arbitrary field, in particular in psychology. For this a digest of quantum mechanics over finite-n-dimensional Hilbert space is invented. In order to match crude data not only von Neumann's mixed states are used but also a parallel notion of unsharp tests. The mathematically styled text (and earlier work on multibin tests, designated MB) deals largely with these new tests. Quantum psychology itself is only given a foundation. It readily engenders objections; its plausibility is developed gradually, in interlocking essays. There is also the empirically definite proposal that (state, test, outcome)-indexed counts be gathered to record data, then fed to a 'matrix format' (MF) search for quantum models. A previously proposed experiment in visual perception which has since failed to find significant quantum correlations, is discussed. The suspicion that quantum mechanics is all around goes beyond MF, and 'Schroedinger's cat' symbolizes this broader perspective. (author)

  7. FDA regulation of tobacco: blessing or curse for FDA professionals?

    Science.gov (United States)

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  8. Domestic cat

    Science.gov (United States)

    Diffendorfer, James E.

    2017-01-01

    The familiar domestic cat is not native to southern California and is considered an invasive spe-cies by biologists and conservation organizations. When owners abandon their cats, wild or feral populations may arise, as they have in San Diego County. Cats’ pelage color, tail length, and hair thickness vary widely, given human fascination with breeding diverse phenotypes, but all have a typical felid body with upright ears, forward-looking eyes adapted for nocturnal foraging, protractible claws, and a sinuous, flexible body. Cats allowed outdoors and feral cats kill and eat a wide variety of vertebrates such as small mammals, birds, and reptiles

  9. FDA Peanut-Containing Product Recall

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...

  10. [U.S. Food and Drug Administration (FDA) strengthens warning that non-aspirin non steroidal anti-inflammatory drugs (NSAIDs) can cause myocardial infarctions or strokes: the dentist's perspective].

    Science.gov (United States)

    Rosen, E; Tsesis, I; Vered, M

    2015-10-01

    This short communication is aimed to update dental practitioners regarding the recently published warning of the U.S. Food and Drug Administration (FDA) regarding the risk for severe cardiovascular complications such as myocardial infarction or stroke following the use of non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs).

  11. Perspectives provided by leopard and other cat genomes: how diet determined the evolutionary history of carnivores, omnivores, and herbivores.

    Science.gov (United States)

    Kim, Soonok; Cho, Yun Sung; Bhak, Jong; O'Brian, Stephen J; Yeo, Joo-Hong

    2017-01-01

    Recent advances in genome sequencing technologies have enabled humans to generate and investigate the genomes of wild species. This includes the big cat family, such as tigers, lions, and leopards. Adding the first high quality leopard genome, we have performed an in-depth comparative analysis to identify the genomic signatures in the evolution of felid to become the top predators on land. Our study focused on how the carnivore genomes, as compared to the omnivore or herbivore genomes, shared evolutionary adaptations in genes associated with nutrient metabolism, muscle strength, agility, and other traits responsible for hunting and meat digestion. We found genetic evidence that genomes represent what animals eat through modifying genes. Highly conserved genetically relevant regions were discovered in genomes at the family level. Also, the Felidae family genomes exhibited low levels of genetic diversity associated with decreased population sizes, presumably because of their strict diet, suggesting their vulnerability and critical conservation status. Our findings can be used for human health enhancement, since we share the same genes as cats with some variation. This is an example how wildlife genomes can be a critical resource for human evolution, providing key genetic marker information for disease treatment. [BMB Reports 2017; 50(1): 3-4].

  12. Cat's Claw

    Science.gov (United States)

    ... R S T U V W X Y Z Cat's Claw Share: On This Page Background How Much ... Foster This fact sheet provides basic information about cat’s claw—common names, usefulness and safety, and resources ...

  13. FDA Approves Lutathera for Neuroendocrine Tumors

    Science.gov (United States)

    FDA has approved Lutathera® for some people with neuroendocrine tumors (NETs) that affect the digestive tract. On January 29, FDA approved Lutathera® for adult patients with advanced NETs that affect the pancreas or gastrointestinal tract, known as GEP-NETs.

  14. Katsvanga, CAT

    African Journals Online (AJOL)

    Katsvanga, CAT. Vol 1, No 2 (2006) - Articles Eucalyptus species performance under short rotation conditions on the Vumba highlands in Zimbabwe Abstract PDF. ISSN: 1819-3692. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians · for Authors · FAQ's · More about AJOL · AJOL's Partners ...

  15. A Catalogue of Anatomical Fugitive Sheets: Cat. 49-62

    OpenAIRE

    1999-01-01

    Images Cat. 50 Cat. 51 Cat. 53 Cat. 54 Cat. 55 (a) Cat. 55 (b) Cat. 56 Cat. 57: 1 Cat. 57: 2 Cat. 57: 3 Cat. 57: 4 Cat. 59: 1 Cat. 59: 2 Cat. 59: 3 Cat. 59: 4 Cat. 60 Cat. 61 Cat. 62: 1 (a) Cat. 62: 1 (b) Cat. 62: 2 (a) Cat. 62: 2 (b)

  16. A Catalogue of Anatomical Fugitive Sheets: Cat. 26-48

    OpenAIRE

    1999-01-01

    Images Cat. 26: 1 (a) Cat. 26: 1 (b) Cat. 26: 2 (a) Cat. 26: 2(b) Cat. 27: 1 (a) Cat. 27: 1 (b) Cat. 27: 2 (a) Cat. 27: 2 (b) Cat. 28 Cat. 29: 2 (a) Cat. 29: 2 (b) Cat. 30: 1 Cat. 30: 2 Cat. 30: 3 Cat. 33 Cat. 34: 1 Cat. 34: 2 Cat. 35: 1 Cat. 35: 2 Cat. 35: 3 Cat. 36 Cat. 37 Cat. 38: 1 Cat. 38: 2 Cat. 40 Cat. 42 Cat. 43 Cat. 44 Cat. 45: 1 Cat. 45: 2 Cat. 46 Cat. 47: 1 Cat. 47: 2 Cat. 47: 3 Cat. 48: 1 Cat. 48: 2 Cat. 48: 3

  17. FDA Regulation of Health and Fitness Equipment

    OpenAIRE

    Moss, Nicole J.

    2000-01-01

    As new "quasi-medical" devices continue to push the bounds of the FDCA definition of a medical device and with growing popular support for using the FDA to regulate previously off-limit products such as tobacco, the FDA may very well broaden its regulatory scope into the health and fitness industry. By focusing on the specific example of the scuba industry, this paper will examine first, whether the FDA has the authority to regulate athletic equipment as medical devices. Part two will explore...

  18. FDA Approves Apalutamide for Prostate Cancer

    Science.gov (United States)

    Apalutamide (Erleada) is a hormone therapy that counteracts resistance to androgen deprivation therapy. Learn more about the FDA approval of apalutamide for men with castration-resistant nonmetastatic prostate cancer in this Cancer Currents blog post.

  19. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  20. FDA and the Chemical Brain Drainers

    DEFF Research Database (Denmark)

    Grandjean, Philippe

    2017-01-01

    Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...

  1. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  2. Cat and Dog Bites

    Science.gov (United States)

    ... Wellness Staying Healthy Pets and Animals Cat and Dog Bites Cat and Dog Bites Share Print Cat and dog bites are common injuries. A family pet or ... bites. Path to safety If a cat or dog bites you, you should: Wash the wound gently ...

  3. FDA Expands Abiraterone Approval for Prostate Cancer

    Science.gov (United States)

    The FDA has expanded the approval of abiraterone (Zytiga) to treat men with metastatic prostate cancer. The agency approved abiraterone, in combination with prednisone, for men whose cancer that is responsive to hormone-blocking treatments (also known as castration-sensitive) and is at high risk of progressing.

  4. FDA regulations for commercial food irradiation

    International Nuclear Information System (INIS)

    Takeguchi, C.A.

    1985-01-01

    The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed

  5. Evaluating eating behavior treatments by FDA standards

    Directory of Open Access Journals (Sweden)

    A. Janet eTomiyama

    2014-01-01

    Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

  6. Mining FDA drug labels for medical conditions.

    Science.gov (United States)

    Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

    2013-04-24

    Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.

  7. Vitamin D discovery outpaces FDA decision making.

    Science.gov (United States)

    Marshall, Trevor G

    2008-02-01

    The US FDA currently encourages the addition of vitamin D to milk and cereals, with the aim of reducing rickets in children and osteoporosis in adults. However, vitamin D not only regulates the expression of genes associated with calcium homeostasis, but also genes associated with cancers, autoimmune disease, and infection. It does this by controlling the activation of the vitamin D receptor (VDR), a type 1 nuclear receptor and DNA transcription factor. Molecular biology is rapidly coming to an understanding of the multiplicity of roles played by the VDR, but clinical medicine is having difficulty keeping up with the pace of change. For example, the FDA recently proposed a rule change that will encourage high levels of vitamin D to be added to even more foods, so that the manufacturers can claim those foods "reduce the risk of osteoporosis". The FDA docket does not review one single paper detailing the transcriptional activity of vitamin D, even though, on average, one new paper a day is being published on that topic. Nor do they review whether widespread supplementation with vitamin D, an immunomodulatory secosteroid, might predispose the population to immune dysfunction. This BioEssay explores how lifelong supplementation of the food chain with vitamin D might well be contributing to the current epidemics of obesity and chronic disease. (c) 2008 Wiley Periodicals, Inc.

  8. Gottlieb, the FDA and dumbing down medicine

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2017-04-01

    Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …

  9. 21 CFR 60.10 - FDA assistance on eligibility.

    Science.gov (United States)

    2010-04-01

    ... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...

  10. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  11. Cat-Scratch Disease

    Science.gov (United States)

    ... Mammals Pet Rodents Wildlife Animal Tales & Features Giant Sharks Help Wounded Warriors Heal Loving Your Special Cat ... bite while they play and learn how to attack prey. How cats and people become infected Kitten ...

  12. Cat Scratch Disease

    Science.gov (United States)

    Cat scratch disease (CSD) is an illness caused by the bacterium Bartonella henselae. Almost half of all cats carry the infection ... symptoms of CSD, call your doctor. Centers for Disease Control and Prevention

  13. Cat Scratch Disease: The Story Continues

    Directory of Open Access Journals (Sweden)

    Mary Anne Opavsky

    1997-01-01

    Full Text Available OBJECTIVE: To present a perspective on the current state of knowledge of cat scratch disease (CSD, including the evidence for Bartonella henselae as the etiological agent, epidemiological and clinical characteristics of the disease, available diagnostic tests and current therapeutic options.

  14. A Catalogue of Anatomical Fugitive Sheets: Cat. 1-10

    OpenAIRE

    1999-01-01

    Images Cat. 1 Cat. 2 (a) Cat. 2 (b) Cat. 2 (c) Cat. 2 (d) Cat. 2 (e) Cat. 2 (f) Cat. 3: 1 (a) Cat. 3: 1 (b) Cat. 3: 2 (a) Cat. 3: 2 (b) Cat. 4: 1 Cat. 4: 2 Cat. 6: 1 (a) Cat. 6: 1 (b) Cat. 6: 2 (a) Cat. 6: 2 (b) Cat. 7: 1 (a) Cat. 7: 1 (b) Cat. 7: 2 (a) Cat. 7: 2 (b) Cat. 8: 1 Cat. 9: 1 Cat. 9: 2 Cat. 10: 1 Cat. 10: 2

  15. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Science.gov (United States)

    2013-03-05

    ... tracing of foods along the supply chain from source to points of service; 6. Demonstrate the tracking and.... The report recommends that each member of the food supply chain should be required to develop..., entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing...

  16. A Catalogue of Anatomical Fugitive Sheets: Cat. 11-25

    OpenAIRE

    1999-01-01

    Images Cat. 11 (a) Cat. 11 (b) Cat. 11 (c) Cat. 11 (d) Cat. 12: 1 (a) Cat. 12: 1 (b) Cat. 12: 2 (a) Cat. 12: 2 (b) Cat. 13 Cat. 14 (a) Cat. 14 (b) Cat. 14 (c) Cat. 15 (a) Cat. 15 (b) Cat. 17: 1 Cat. 17: 2 Cat. 18: 1 Cat. 18: 2 Cat. 19: 1 (a) Cat. 19: 1 (b) Cat. 19: 2 (a) Cat. 19: 2 (b) Cat. 20: 1 Cat. 20: 2 (a) Cat. 20: 2 (b) Cat. 21 (a) Cat. 21 (b) Cat. 21 (c) Cat. 21 (d) Cat. 21 (e) Cat. 22 Cat. 24: 1 and 2 Cat. 25: 1 Cat. 25: 2 Cat. 25: 3 Cat. 25: 4

  17. A tortoiseshell male cat

    DEFF Research Database (Denmark)

    Pedersen, A. S.; Berg, Lise Charlotte; Almstrup, Kristian

    2014-01-01

    Tortoiseshell coat color is normally restricted to female cats due to X-linkage of the gene that encodes the orange coat color. Tortoiseshell male cats do, however, occur at a low frequency among tortoiseshell cats because of chromosome aberrations similar to the Klinefelter syndrome in man...... tissue from a tortoiseshell male cat referred to us. Chromosome analysis using RBA-banding consistently revealed a 39,XXY karyotype. Histological examinations of testis biopsies from this cat showed degeneration of the tubules, hyperplasia of the interstitial tissue, and complete loss of germ cells....... Immunostaining using anti-vimentin and anti-VASA (DDX4) showed that only Sertoli cells and no germ cells were observed in the testicular tubules. As no sign of spermatogenesis was detected, we conclude that this is a classic case of a sterile, male tortoiseshell cat with a 39,XXY chromosome complement. © 2013 S...

  18. FDA advierte sobre cardiotoxicidad de cisaprida

    Directory of Open Access Journals (Sweden)

    Carlos Bustamante Rojas

    1998-07-01

    Full Text Available La FDA y Janssen Phamaceuticals -el fabricante de cisaprida- han advertido mediante cartas a los prescriptores que el fármaco no deberá ser utilizado simultáneamente junto con macrólidos antifúngicos, algunos antidepresivos e inhibidores de las proteasas, ya que puede aparecer prolongación del intervalo QT y severos trastornos del ritmo cardiaco. Adicionalmente, el fármaco está contraindicado en los pacientes con EPOC, ICC, cáncer avanzado y en pacientes can alteraciones del equilibrio hidroelectrolítico como hipomagnesemia o hipokalemia. Igualmente, su uso debe hacerse con bastantes precauciones en los pacientes que reciben insulina y aquellos que presentan náuseas, vómito, diarrea o deshidratación.

  19. Megaesophagus in a Cat

    OpenAIRE

    Forbes, Douglas C.; Leishman, Dyan E.

    1985-01-01

    Megaesophagus in an eight month old Siamese cat is described. Initially, a cause for the vomiting was not discovered and the cat was treated for pyloric spasm. Several months later the same cat, in poor physical condition, was presented with a palpable bulge along its ventral neck. At this time a very dilated and flaccid esophagus was found. An exploratory thoracotomy was done but a cause for the megaesophagus was not discovered.

  20. The FDA's program for monitoring radionuclides in food

    International Nuclear Information System (INIS)

    Baratta, E.J.

    1992-01-01

    The US Food and Drug Administration (FDA) modified its food-monitoring program in 1973 to include radioactive isotopes. There was concern at this time about the possibility of food contamination by effluents from nuclear power plants, some above-ground weapons testing by nonsignatory powers, and increased use of medical and commercial radioactive materials. The FDA decided, therefore, that a radioanalytical capability must be maintained to detect any upward trend of radioactive contamination in food. This capability would also allow the FDA to respond to any incidents that might occur in order to protect the US food supply. This program is located at the FDA's Winchester Engineering and Analytical Center, Winchester, Massachusetts

  1. Changes In Growth Culture FDA Activity Under Changing Growth Conditions

    DEFF Research Database (Denmark)

    Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

    1992-01-01

    of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils......The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...

  2. Tendências católicas: perspectivas do cristianismo da libertação Catholic tendencies: perspectives of the freedom cristianism

    Directory of Open Access Journals (Sweden)

    Flávio Munhoz Sofiati

    2009-04-01

    Full Text Available O texto analisa as diferentes vertentes da Igreja Católica no Brasil, apresentando-as a partir de teóricos da própria Igreja das ciências sociais. Em seguida, discute-se a tendência ligada à Teologia da Libertação, chamada de Cristianismo da Libertação. Afirma-se que o conceito de “Tendências Internas do Catolicismo” é mais apropriado para compreender os processos internos do catolicismo e que, atualmente, a Teologia da Libertação vem perdendo espaço no cenário religioso. Isso ocorre em virtude de questões internas – como o fortalecimento do movimento carismático – e externas – como o advento do neoliberalismo. Diante dessa situação, esse segmento assume uma nova postura de atuação, que tem como idéia central a construção de mudanças “de baixo para cima” e em longo prazo. Conclui-se que houve um recuo programático dessa tendência que passa a priorizar sua ação no interior da Igreja e a valorizar temas como espiritualidade, ecologia e cultura em detrimento da dimensão política. Palavras-chaves: Sociologia da Religião. Catolicismo. Tendências católicas. Teologia da libertação. The text analyzes different aspects of the Catholic Church in Brazil, presenting them through theories of the church, from social sciences. After that there is a discussion about the tendency connected to the Theory of Freedom, so called “Freedom Cristianism”. It is said that the concept of “Inner Theories of Catholicism” is more appropriate to understand the inner processes of the Catholicism and that, nowadays, the Freedom Theory has been loosing space inside the religious scenery. This occurs due to inner reasons – such as the growing strength of the charismatic movement – and also due to external reasons – as the ascending of Neoliberalism. With that, this segment gets to a new posture of action which has as central idea the“from down to up” changes, during long terms. After all, there is the

  3. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    Science.gov (United States)

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  4. That Fat Cat

    Science.gov (United States)

    Lambert, Phyllis Gilchrist

    2012-01-01

    This activity began with a picture book, Nurit Karlin's "Fat Cat On a Mat" (HarperCollins; 1998). The author and her students started their project with a 5-inch circular template for the head of their cats. They reviewed shapes as they drew the head and then added the ears and nose, which were triangles. Details to the face were added when…

  5. CAT questions and answers

    International Nuclear Information System (INIS)

    1993-02-01

    This document, prepared in February 1993, addresses the most common questions asked by APS Collaborative Access Teams (CATs). The answers represent the best judgment on the part of the APS at this time. In some cases, details are provided in separate documents to be supplied by the APS. Some of the answers are brief because details are not yet available. The questions are separated into five categories representing different aspects of CAT interactions with the APS: (1) Memorandum of Understanding (MOU), (2) CAT Beamline Review and Construction, (3) CAT Beamline Safety, (4) CAT Beamline Operations, and (5) Miscellaneous. The APS plans to generate similar documents as needed to both address new questions and clarify answers to present questions

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

  7. Implementing computerized adaptive tests in routine clinical practice: experience implementing CATs.

    Science.gov (United States)

    Hart, Dennis L; Deutscher, Daniel; Werneke, Mark W; Holder, Judy; Wang, Ying-Chih

    2010-01-01

    This paper traces the development, testing and use of CATs in outpatient rehabilitation from the perspective of one proprietary international medical rehabilitation database management company, Focus On Therapeutic Outcomes, Inc. (FOTO). Between the FOTO data in the United States and Maccabi Healthcare Services data in Israel, over 1.5 million CATs have been administered. Using findings from published studies and results of internal public relations surveys, we discuss (1) reasons for CAT development, (2) how the CATs were received by clinicians and patients in the United States and Israel, (3) results of psychometric property assessments of CAT estimated measures of functional status in routine clinical practice, (4) clinical interpretation of CAT functional status measures, and (5) future development directions. Results of scientific studies and business history provide confidence that CATs are pertinent and valuable to clinicians, patients and payers, and suggest CATs will be prominent in the development of future integrated computerized electronic medical record systems with electronic outcomes data collection.

  8. FDA licensure of and ACIP recommendations for vaccines.

    Science.gov (United States)

    Pickering, Larry K; Orenstein, Walter A; Sun, Wellington; Baker, Carol J

    2017-09-05

    Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Changes In Growth Culture FDA Activity Under Changing Growth Conditions

    DEFF Research Database (Denmark)

    Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

    1992-01-01

    The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....

  10. Cat-scratch neuroretinitis.

    Science.gov (United States)

    Lombardo, J

    1999-08-01

    Cat-scratch disease is a subacute regional lymphadenitis, usually preceded by a history of a cat scratch or exposure to kittens. The disease is caused by Bartonella henselae, and possibly Bartonella quintana, pleomorphic gram-negative rods formerly known as Rochalimaea henselae and Rochalimaea quintana. Ocular involvement is rare and typically manifests as either Parinaud's oculoglandular syndrome or neuroretinitis. Patients with neuroretinitis resulting from cat-scratch disease may be asymptomatic or experience mild-to-severe vision loss. The clinical features, angiographic appearance, differential diagnosis, and management of cat-scratch neuroretinitis are discussed. A 30-year-old white woman reported to the eye clinic with painless, decreased vision in the right eye. A diagnosis of cat scratch neuroretinitis was made on the basis of the history of cat scratch, clinical appearance, and angiographic findings. Treatment with oral ciprofloxacin restored vision to normal in 4 weeks. Painless vision loss associated with optic nerve swelling and macular star exudate should alert suspicion of systemic disease. Additional findings--including positive history of a cat scratch, lymphadenopathy, and flu-like symptoms--may indicate Bartonella henselae or Bartonella quintana infection. While treatment remains controversial, appropriate serology testing may aid in the diagnosis and management of the underlying infection.

  11. Real-World Evidence, Public Participation, and the FDA.

    Science.gov (United States)

    Schwartz, Jason L

    2017-11-01

    For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

  12. IndexCat

    Data.gov (United States)

    U.S. Department of Health & Human Services — IndexCat provides access to the digitized version of the printed Index-Catalogue of the Library of the Surgeon General's Office; eTK for medieval Latin texts; and...

  13. StreamCat

    Data.gov (United States)

    U.S. Environmental Protection Agency — The StreamCat Dataset provides summaries of natural and anthropogenic landscape features for ~2.65 million streams, and their associated catchments, within the...

  14. Cat-Scratch Disease

    Science.gov (United States)

    ... pain. Antibiotics may be needed if your symptoms don’t go away in a month or two. In rare cases, the infection can travel to your bones, liver, or other organs. This requires more intensive treatment. Should cats be ...

  15. Dose Matters: FDA's Guidance on Children's X-rays

    Science.gov (United States)

    ... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...

  16. 75 FR 76992 - Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing...

    Science.gov (United States)

    2010-12-10

    ... CFR 14.29. FDA encourages participation from all public stakeholders in our decisionmaking processes... speak at an OPH session, logistical procedures, and disclosure of financial relationships relevant to...

  17. Perspectives

    Indian Academy of Sciences (India)

    Unknown

    Developmental mechanisms: putting genes in their place. STUART A NEWMAN. Department of Cell Biology ... effects, multifactoriality and func- tional redundancy of gene action in the determination of. Perspectives .... The vertebrate seg- mental plate becomes sequentially partitioned into paired somites by a process that ...

  18. Pancreatitis in cats.

    Science.gov (United States)

    Armstrong, P Jane; Williams, David A

    2012-08-01

    Pancreatitis was considered a rare disease in the cat until a couple of decades ago when several retrospective studies of severe acute pancreatitis were published. It was apparent that few of the diagnostic tests of value in the dog were helpful in cats. With increasing clinical suspicion, availability of abdominal ultrasonography, and introduction of pancreas-specific blood tests of increasing utility, it is now accepted that acute pancreatitis is probably almost as common in cats as it is in dogs, although the etiology(s) remain more obscure. Pancreatitis in cats often co-exists with inflammatory bowel disease, less commonly with cholangitis, and sometimes with both. Additionally, pancreatitis may trigger hepatic lipidosis, while other diseases, such as diabetes mellitus, may be complicated by pancreatitis. Therapy is similar to that used in dogs, with added emphasis on early nutritional support to prevent hepatic lipidosis. Less is known about chronic pancreatitis than the acute form, but chronic pancreatitis is more common in cats than it is in dogs and may respond positively to treatment with corticosteroids. Copyright © 2012. Published by Elsevier Inc.

  19. E-Z-CAT

    International Nuclear Information System (INIS)

    Nyman, U.; Dinnetz, G.; Andersson, I.

    1984-01-01

    A new barium sulphate suspension, E-Z-CAT, for use as an oral contrast medium at computed tomography of the abdomen has been compared with the commonly used water-soluble iodinated contrast medium Gastrografin as regards patient tolerance and diagnostic information. The investigation was conducted as an unpaired randomized single-blind study in 100 consecutive patients. E-Z-CAT seems to be preferred because of its better taste, its lesser tendency to cause diarrhoea, and for usage in patients who are known to be hypersensitive to iodinated contrast media. The diagnostic information was the same for both contrast media. (Auth.)

  20. [Declawing in cats?].

    Science.gov (United States)

    de Jonge, I

    1983-02-15

    Those forms of behaviour in which cats use their claws are reviewed. Forms of undesirable use of the claws and possible solutions to this problem are discussed. An inquiry among veterinary practitioners showed that nearly fifty per cent of these practitioners refused to declaw cats on principle. Approximately seventy-five per cent of the veterinarians taking part in the inquiry advocated that the Royal Netherlands Veterinary Association should state its position with regard to declawing. It is concluded by the present author that declawing is unacceptable for ethical and ethological reasons.

  1. Attitudes Toward FDA Regulation of Newly Deemed Tobacco Products.

    Science.gov (United States)

    Kowitt, Sarah D; Goldstein, Adam O; Schmidt, Allison M; Hall, Marissa G; Brewer, Noel T

    2017-10-01

    To examine how smokers perceive FDA oversight of e-cigarettes, hookah, and cigars. Current US smokers (N = 1,520) participating in a randomized clinical trial of pictorial cigarette pack warnings completed a survey that included questions about attitudes toward new FDA regulations covering newly deemed tobacco products (ie, regulation of e-cigarettes, nicotine gels or liquids used in e-cigarettes, hookah, and cigars). Between 47% and 56% of current smokers viewed these new FDA regulations favorably and between 17% - 24% opposed them. Favorable attitudes toward the regulations were more common among smokers with higher quit intentions (adjusted odds ratio (aOR): 1.17, 95% CI: 1.02, 1.33) and more negative beliefs about smokers (aOR: 1.18, 95% CI: 1.05, 1.33). Participants with higher education, higher income, and previous exposure to e-cigarette advertisements had higher odds of expressing positive attitudes toward the new FDA regulations (p FDA regulation of newly deemed tobacco products favorably. Local and state policy-makers and tobacco control advocates can build on this support to enact and strengthen tobacco control provisions for e-cigarettes, cigars, and hookah.

  2. Healthy public relations: the FDA's 1930s legislative campaign.

    Science.gov (United States)

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

  3. Tracheal collapse in two cats

    International Nuclear Information System (INIS)

    Hendricks, J.C.; O'Brien, J.A.

    1985-01-01

    Two cats examined bronchoscopically to discover the cause of tracheal collapse were found to have tracheal obstruction cranial to the collapse. Cats with this unusual sign should be examined bronchoscopically to ascertain whether there is an obstruction, as the cause in these 2 cats was distinct from the diffuse airway abnormality that causes tracheal collapse in dogs

  4. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Science.gov (United States)

    2010-05-21

    ...] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U... Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and... relates to FDA's policies on disclosure of information to the public about FDA activities. FDA is...

  5. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Science.gov (United States)

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization...

  6. Collaborative Assessment Tool (CAT) - Assessing scientific practices in introductory physics

    Science.gov (United States)

    Irving, Paul

    2017-01-01

    An important learning goal of Projects and Practices in Physics (P3) , the transformed introductory mechanics course at Michigan State University, is the development of scientific practices. The design team, as part of the P3 course construction, made clear attempts to assess learning goals that can often be perceived as being a part of the hidden curriculum or considered difficult to assess (e.g., learning to work productively in a group) by developing a collaborative assessment tool (CAT). The CAT is a formative assessment tool that provides students with a numerical grade for how they participated in their learning group on a weekly basis while also providing feedback in the form of written commentary and suggestions on how they might improve at a particular collaborative practice. In this presentation, we demonstrate the CAT tool from two perspectives: 1) how the CAT tool is used within the P3 context and 2) how the formative feedback has affected changes in student interactions in class. We will present the case studies of 3 students who had differing reactions to the feedback they received. We will explore the role the feedback had in their interactions over a four-week period from an in-class perspective and a reflected perspective through interviews and observations. The analysis will also be presented from a tutor and group perspective, which will highlight the affordances the CAT can have in creating a productive learning group. The research on the CAT shows promise in encouraging growth in students' collaborative skills, but this research is still in its infancy and needs to be expanded to include different contexts.

  7. Prostatic carcinoma in two cats

    International Nuclear Information System (INIS)

    Caney, S.M.A.; Holt, P.E.; Day, M.J.; Rudorf, H.; Gruffydd-Jones, T.J.

    1998-01-01

    Clinical, radiological and pathological features of two cats with prostatic carcinoma are reported. In both cats the presenting history included signs of lower urinary tract disease with haematuria and dysuria. Prostatomegaly was visible radiographically in one cat; an irregular intraprostatic urethra was seen on retrograde contrast urethrography in both cats. In one of the cats, neoplasia was suspected on the basis of a transurethral catheter biopsy. Following a poor response to palliative treatment in both cases, euthanasia was performed with histological confirmation of the diagnosis

  8. Perspective

    DEFF Research Database (Denmark)

    Kussmann, Martin; Morine, Melissa J; Hager, Jörg

    2013-01-01

    We review here the status of human type 2 diabetes studies from a genetic, epidemiological, and clinical (intervention) perspective. Most studies limit analyses to one or a few omic technologies providing data of components of physiological processes. Since all chronic diseases are multifactorial...... and arise from complex interactions between genetic makeup and environment, type 2 diabetes mellitus (T2DM) is a collection of sub-phenotypes resulting in high fasting glucose. The underlying gene-environment interactions that produce these classes of T2DM are imperfectly characterized. Based on assessments...... of the complexity of T2DM, we propose a systems biology approach to advance the understanding of origin, onset, development, prevention, and treatment of this complex disease. This systems-based strategy is based on new study design principles and the integrated application of omics technologies: we pursue...

  9. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

    2015-01-01

    Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

  10. FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

    NARCIS (Netherlands)

    Grossman, M.R.

    2014-01-01

    268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the

  11. FDA Expands Approval of Brentuximab for Hodgkin Lymphoma

    Science.gov (United States)

    The FDA has expanded the approved uses of brentuximab (Adcetris) in people with Hodgkin lymphoma. As this Cancer Currents post explains, it can now be used in combination with three chemotherapy drugs as an initial treatment in patients with advanced disease.

  12. FDA Drug Safety Podcasts: resources for drug information.

    Science.gov (United States)

    Wu, Kimberly; Shepherd, Jennifer; Jackson, Steven; Chew, Catherine

    2013-01-01

    To describe a Web-based drug information service provided by the Food and Drug Administration (FDA) to increase the reach of Drug Safety Communications to pharmacists and other health professionals. The Division of Drug Information (DDI) within the FDA Center for Drug Evaluation and Research (CDER), Office of Communications, Silver Spring, MD, between January 2010 and April 2012. DDI provides drug information services regarding human drug products and expert advice and guidance on all aspects of CDER activities. Customers include consumers, health professionals, regulated industry, insurance companies, academia, law enforcement, and other government agencies (national and international). Use of audio podcasts to disseminate timely drug safety information targeted toward pharmacists and other health professionals. RESULTS Since 2010, DDI has recorded and published 119 FDA Drug Safety Podcasts that have reached more than 620,000 individuals. FDA Drug Safety Podcasts serve as portable and convenient options for pharmacists to stay current on the latest drug safety information. Pharmacists are encouraged to explore incorporating Web-based technologies, such as audio podcasts, into their practices.

  13. 21 CFR 5.1110 - FDA public information offices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...

  14. Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

    Science.gov (United States)

    Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini

    2009-01-01

    This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

  15. Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

    Science.gov (United States)

    McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

    2017-01-01

    Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

  16. Local cloning of CAT states

    International Nuclear Information System (INIS)

    Rahaman, Ramij

    2011-01-01

    In this Letter we analyze the (im)possibility of the exact cloning of orthogonal three-qubit CAT states under local operation and classical communication (LOCC) with the help of a restricted entangled state. We also classify the three-qubit CAT states that can (not) be cloned under LOCC restrictions and extend the results to the n-qubit case. -- Highlights: → We analyze the (im)possibility of exact cloning of orthogonal CAT states under LOCC. → We also classify the set of CAT states that can(not) be cloned by LOCC. → No set of orthogonal CAT states can be cloned by LOCC with help of similar CAT state. → Any two orthogonal n-qubit GHZ-states can be cloned by LOCC with help of a GHZ state.

  17. European Medicines Agency, CAT Secretariat & US Food and Drug Administration.

    Science.gov (United States)

    2011-11-01

    The European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) are responsible for reviewing applications for marketing authorization for Advanced Therapy Medicinal Products (ATMP), which include (stem) cell-based medicines, for the ATMP classification and certification procedure, and to provide scientific advice to developers of ATMPs. The CAT, an expert committee dedicated to ATMPs, was established by the Regulation (EC) No 1394/2007 on Advanced Therapies. The CAT came into operation in January 2009. ATMPs are defined in this Regulation as gene therapy and cell therapy medicinal products, and tissue-engineered products. The US FDA's Center for Biologics Evaluation and Research is responsible for ensuring the safety, purity, potency and effectiveness of many biologically derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products for the prevention, diagnosis and treatment of human diseases, conditions or injury. Human cells or tissue intended for implantation, transplantation, infusion or transfer into a human recipient are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).

  18. Cystinuria in a cat.

    Science.gov (United States)

    DiBartola, S P; Chew, D J; Horton, M L

    1991-01-01

    A 10-month-old male Siamese cat with dysuria was determined to have cystine crystalluria. Many small calculi composed entirely of cystine were found in the urinary bladder. Measurement of serum and urine amino acids and calculation of fractional reabsorption of amino acids indicated reabsorption defects for cystine, ornithine, lysine, and arginine. Urinary acidification, fractional reabsorption of glucose, and fractional reabsorption of electrolytes were normal. Diagnoses of cystinuria and cystine urolithiasis were made on the basis of low fractional reabsorption of cystine and dibasic amino acids and the detection of cystine calculi in the urinary bladder.

  19. The FDA "Deeming Rule" and Tobacco Regulatory Research.

    Science.gov (United States)

    Backinger, Cathy L; Meissner, Helen I; Ashley, David L

    2016-07-01

    In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of mechanisms, including partnership with the Tobacco Regulatory Science Program, National Institutes of Health. In building the evidence base to inform the regulation of and communications about new and emerging tobacco products, it is important for investigators to be mindful of the goals of tobacco regulatory science, ie, scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public's health. Having solid scientific evidence will allow the FDA to make the most appropriate regulatory decisions regarding newly deemed products.

  20. FDA actions against health economic promotions, 2002-2011.

    Science.gov (United States)

    Neumann, Peter J; Bliss, Sarah K

    2012-01-01

    To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  1. Advancing women's health via FDA Critical Path Initiative.

    Science.gov (United States)

    Parekh, A; Sanhai, W; Marts, S; Uhl, K

    2007-01-01

    Studying sex and gender differences is critical to understanding diseases that affect women solely, disproportionately or differently from men. Although inclusion of both sexes is essential in clinical research, advanced technology and analysis methods offer tools to define complex biological and physicochemical differences and improve prevention, diagnosis and treatments for diseases in women and men. This paper identifies the potential for biomarker development, pharmacogenetics and bioinformatics in research under the FDA Critical Path Initiative.: � 2007 Elsevier Ltd . All rights reserved.

  2. Current and future state of FDA-CMS parallel reviews.

    Science.gov (United States)

    Messner, D A; Tunis, S R

    2012-03-01

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

  3. Toxoplasmosis: An Important Message for Cat Owners

    Science.gov (United States)

    ... role do cats play in the spread of toxoplasmosis? Cats get Toxoplasma infection by eating infected rodents, ... an infected cat may have defecated. What is toxoplasmosis? Toxoplasmosis is an infection caused by a microscopic ...

  4. Convergence and divergence in the evolution of cat skulls: temporal and spatial patterns of morphological diversity.

    Directory of Open Access Journals (Sweden)

    Manabu Sakamoto

    Full Text Available Studies of biological shape evolution are greatly enhanced when framed in a phylogenetic perspective. Inclusion of fossils amplifies the scope of macroevolutionary research, offers a deep-time perspective on tempo and mode of radiations, and elucidates life-trait changes. We explore the evolution of skull shape in felids (cats through morphometric analyses of linear variables, phylogenetic comparative methods, and a new cladistic study of saber-toothed cats.A new phylogenetic analysis supports the monophyly of saber-toothed cats (Machairodontinae exclusive of Felinae and some basal felids, but does not support the monophyly of various saber-toothed tribes and genera. We quantified skull shape variation in 34 extant and 18 extinct species using size-adjusted linear variables. These distinguish taxonomic group membership with high accuracy. Patterns of morphospace occupation are consistent with previous analyses, for example, in showing a size gradient along the primary axis of shape variation and a separation between large and small-medium cats. By combining the new phylogeny with a molecular tree of extant Felinae, we built a chronophylomorphospace (a phylogeny superimposed onto a two-dimensional morphospace through time. The evolutionary history of cats was characterized by two major episodes of morphological divergence, one marking the separation between saber-toothed and modern cats, the other marking the split between large and small-medium cats.Ancestors of large cats in the 'Panthera' lineage tend to occupy, at a much later stage, morphospace regions previously occupied by saber-toothed cats. The latter radiated out into new morphospace regions peripheral to those of extant large cats. The separation between large and small-medium cats was marked by considerable morphologically divergent trajectories early in feline evolution. A chronophylomorphospace has wider applications in reconstructing temporal transitions across two

  5. Systemic Cat Scratch Disease

    Directory of Open Access Journals (Sweden)

    Hui-Min Liao

    2006-01-01

    Full Text Available Systemic cat scratch disease (CSD is often associated with prolonged fever and microabscesses in the liver and/or spleen. We report a case of systemic CSD with hepatic, splenic and renal involvement in an aboriginal child in Taiwan. A previously healthy 9-year-old girl had an intermittent fever for about 17 days, and complained of abdominal pain, headache and weight loss. Abdominal computed tomography showed multiple tiny hypodense nodular lesions in the spleen and both kidneys. Laparotomy revealed multiple soft, whitishtan lesions on the surface of the liver and spleen. Histopathologic examination of a biopsy specimen of the spleen showed necrotizing granulomatous inflammation with central necrosis surrounded by epithelioid cells and occasional Langhans' giant cells, strongly suggestive of Bartonella henselae infection. History revealed close contact with a cat. B. henselae DNA was detected by polymerase chain reaction in the tissue specimen, and the single antibody titer against B. henselae was greater than 1:2048. These results confirmed the diagnosis of visceral CSD caused by B. henselae. The patient's symptoms resolved after treatment with rifampin and tetracycline. This case illustrates the need for inclusion of systemic CSD in patients with fever of unknown origin and abdominal pain.

  6. Lumbosacral agenesis in a cat

    OpenAIRE

    Gabrielle C Hybki; Lisa A Murphy; Joseph P Marchi; Jeffrey E Patlogar; Jennifer O Brisson; Reid K Nakamura

    2016-01-01

    Case summary Lumbosacral agenesis is a rare congenital condition reported in children. We report a 17-week-old female domestic shorthair cat with lumbosacral agenesis on whole-body radiographs. The cat was euthanized shortly thereafter presentation. A necropsy was not permitted. Relevance and novel information This is the first reported feline case of lumbosacral agenesis.

  7. Rebound hyperglycaemia in diabetic cats.

    Science.gov (United States)

    Roomp, Kirsten; Rand, Jacquie

    2016-08-01

    Rebound hyperglycaemia (also termed Somogyi effect) is defined as hyperglycaemia caused by the release of counter-regulatory hormones in response to insulin-induced hypoglycaemia, and is widely believed to be common in diabetic cats. However, studies in human diabetic patients over the past quarter century have rejected the common occurrence of this phenomenon. Therefore, we evaluated the occurrence and prevalence of rebound hyperglycaemia in diabetic cats. In a retrospective study, 10,767 blood glucose curves of 55 cats treated with glargine using an intensive blood glucose regulation protocol with a median of five blood glucose measurements per day were evaluated for evidence of rebound hyperglycaemic events, defined in two different ways (with and without an insulin resistance component). While biochemical hypoglycaemia occurred frequently, blood glucose curves consistent with rebound hyperglycaemia with insulin resistance was confined to four single events in four different cats. In 14/55 cats (25%), a median of 1.5% (range 0.32-7.7%) of blood glucose curves were consistent with rebound hyperglycaemia without an insulin resistance component; this represented 0.42% of blood glucose curves in both affected and unaffected cats. We conclude that despite the frequent occurrence of biochemical hypoglycaemia, rebound hyperglycaemia is rare in cats treated with glargine on a protocol aimed at tight glycaemic control. For glargine-treated cats, insulin dose should not be reduced when there is hyperglycaemia in the absence of biochemical or clinical evidence of hypoglycaemia. © ISFM and AAFP 2015.

  8. Lumbosacral agenesis in a cat

    Directory of Open Access Journals (Sweden)

    Gabrielle C Hybki

    2016-01-01

    Full Text Available Case summary Lumbosacral agenesis is a rare congenital condition reported in children. We report a 17-week-old female domestic shorthair cat with lumbosacral agenesis on whole-body radiographs. The cat was euthanized shortly thereafter presentation. A necropsy was not permitted. Relevance and novel information This is the first reported feline case of lumbosacral agenesis.

  9. Local cloning of CAT states

    Science.gov (United States)

    Rahaman, Ramij

    2011-06-01

    In this Letter we analyze the (im)possibility of the exact cloning of orthogonal three-qubit CAT states under local operation and classical communication (LOCC) with the help of a restricted entangled state. We also classify the three-qubit CAT states that can (not) be cloned under LOCC restrictions and extend the results to the n-qubit case.

  10. College Students and Their Cats

    Science.gov (United States)

    Weinstein, Lawrence; Alexander, Ralph

    2010-01-01

    Twenty-two Siamese and 32 mixed breed cats' personalities were rated by their respective college student owners and compared. Further, the owners' self rated personality traits were correlated with the pets'; significant Siamese and Mixed differences and correlations were obtained. These are the first data to examine breed of cat on a personality…

  11. CONTRACT ADMINISTRATIVE TRACKING SYSTEM (CATS)

    Science.gov (United States)

    The Contract Administrative Tracking System (CATS) was developed in response to an ORD NHEERL, Mid-Continent Ecology Division (MED)-recognized need for an automated tracking and retrieval system for Cost Reimbursable Level of Effort (CR/LOE) Contracts. CATS is an Oracle-based app...

  12. The role of the FDA in the effort against AIDS.

    Science.gov (United States)

    Young, F E

    1988-01-01

    The Food and Drug Administration has instituted several pro-active measures to expedite the review of treatments, diagnostics, and vaccines for AIDS and related conditions. In particular, the agency has established a special designation--1-AA--for a potential AIDS product which gives top priority to its review. This special expedited review process for AIDS products has provided for greater cooperation between their sponsors and FDA's reviewers. AIDS products also receive prompt consideration for orphan product status--a status providing financial incentives to the developers of treatments for certain rare and complex diseases. FDA's special procedures for AIDS drugs have resulted in several major advances in available AIDS treatments. Foremost among these was the FDA's review and approval of zidovudine (commonly known as AZT) as the first effective palliative for AIDS within 107 days--an agency record. Similarly, the agency quickly evaluated and approved ELISA and Western blot diagnostic kits for detecting the presence of HIV antibody. These test kits have made an important contribution to safeguarding the nation's blood supply. The agency has also instituted new "treatment" investigational new drug regulations to allow earlier pre-approval distribution of promising experimental treatments to patients with immediately life-threatening conditions, including persons with AIDS. Under this system and its earlier prototype, eligible AIDS patients were able to receive pre-approval treatment with zidovudine and trimetrexate (an experimental drug for the treatment of AIDS patients with Pneumocystis carinii pneumonia who have experienced severe adverse reactions using standard approved therapies). The agency has made institutional reforms to effectively streamline the review of candidate AIDS treatments and vaccines. Two new centers within the agency have been established for the processing of drug and biologics. In addition,reviewing divisions have been created within

  13. No sisyphean task: how the FDA can regulate electronic cigarettes.

    Science.gov (United States)

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  14. Peritoneopericardial diaphragmatic hernia in cats

    International Nuclear Information System (INIS)

    Neiger, R.

    1996-01-01

    Peritoneopericardial diaphragmatic hernia in a cat is often an incidental finding on a routine thoracic or abdominal radiograph. Clinical signs are nonspecific-usually respiratory (dyspnea) or gastrointestinal(vomiting or diarrhea). Some of the cats with this anomaly are asymptomatic. The physical examination may be normal: muffled heart sounds are the most common abnormality noted during a physical examination. Cats of many breeds are affected, although 26% of reported cases were inPersians. Age of the cat at diagnosis ranged from 6 days to 14 years. Thirty of the 52 reported cases were in females. Diagnostic studies used to confirm the diagnosis included echocardiography, upper gastrointestinal study, ultrasonography, angiography, positive-contrast peritoneography, and laparotomy. Surgical correction was reportedly successful in 22 of 25 cats

  15. 76 FR 38666 - Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island...

    Science.gov (United States)

    2011-07-01

    ..., FDA must stay abreast of the latest developments in research and also communicate with stakeholders... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0012] Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab...

  16. Toxoplasmosis : Beware of Cats !!!

    Directory of Open Access Journals (Sweden)

    Rubina Kumari Baithalu

    2010-10-01

    Full Text Available Anthropozoonotic parasite Toxoplasma gondii causes widespread human and animal diseases, mostly involving central nervous system. Human acquires toxoplasmosis from cats, from consuming raw or undercooked meat and from vertical transmission to the fetus through placenta from mother during pregnancy. Socio-epidemiological as well as unique environmental factors also plays a significant role in transmission of this infection. Preventive measures should be taken into account the importance of culture, tradition, and beliefs of people in various communities more than solving poverty and giving health education. Therefore the focus of this article is to create public awareness regarding sense of responsibility of looking after pets to prevent such an important zoonotic disease. [Vet. World 2010; 3(5.000: 247-249

  17. CAT-D-T tokamaks

    International Nuclear Information System (INIS)

    Greenspan, E.; Blue, T.; Miley, G.H.

    1981-01-01

    The domains of plasma fuel cycles bounded by the D-T and Cat-D, and by the D-T and SCD modes of operation are examined. These domains, referred to as, respectively, the Cat-D-T and SCD-T modes of operation, are characterized by the number (γ) of tritons per fusion neutron available from external (to the plasma) sources. Two external tritium sources are considered - the blankets of the Cat-D-T (SCD-T) reactors and fission reactors supported by the Cat-D-T (SCD-T) driven hybrid reactors. It is found that by using 6 Li for the active material of the control elements of the fission reactors, it is possible to achieve γ values close to unity. Cat-D-T tokamaks could be designed to have smaller size, higher power density, lower magnetic field and even lower plasma temperature than Cat-D tokamaks; the difference becomes significant for γ greater than or equal to .75. The SCD-T mode of operation appears to be even more attractive. Promising applications identified for these Cat-D-T and SCD-T modes of operation include hybrid reactors, fusion synfuel factories and fusion reactors which have difficulty in providing all their tritium needs

  18. Sonography of cat scratch disease.

    Science.gov (United States)

    Melville, David M; Jacobson, Jon A; Downie, Brian; Biermann, J Sybil; Kim, Sung Moon; Yablon, Corrie M

    2015-03-01

    To characterize the sonographic features of cat scratch disease and to identify features that allow differentiation from other causes of medial epitrochlear masses. After Institutional Review Board approval was obtained, patients who underwent sonography for a medial epitrochlear mass or lymph node were identified via the radiology information system. Patients were divided into 2 groups: cat scratch disease and non-cat scratch disease, based on pathologic results and clinical information. Sonograms were retrospectively reviewed and characterized with respect to dimension, shape (round, oval, or lobular), symmetry, location (subcutaneous or intramuscular), multiplicity, echogenicity (anechoic, hypoechoic, isoechoic, hyperechoic, or mixed), hyperechoic hilum (present or absent), adjacent anechoic or hypoechoic area, hyperemia (present or absent), pattern of hyperemia if present (central, peripheral, or mixed), increased posterior through-transmission (present or absent), and shadowing (present or absent). Sonographic findings were compared between the patients with and without cat scratch disease. The final patient group consisted of 5 cases of cat scratch disease and 16 cases of other causes of medial epitrochlear masses. The 2 sonographic findings that were significantly different between the cat scratch disease and non-cat scratch disease cases included mass asymmetry (P = .0062) and the presence of a hyperechoic hilum (P = .0075). The other sonographic findings showed no significant differences between the groups. The sonographic finding of an epitrochlear mass due to cat scratch disease most commonly is that of a hypoechoic lobular or oval mass with central hyperemia and a possible adjacent fluid collection; however, the presence of asymmetry and a hyperechoic hilum differentiate cat scratch disease from other etiologies. © 2015 by the American Institute of Ultrasound in Medicine.

  19. Public opinion about FDA regulation of menthol and nicotine.

    Science.gov (United States)

    Bolcic-Jankovic, Dragana; Biener, Lois

    2015-12-01

    Regulations that reduce nicotine and eliminate menthol in cigarettes have been proposed to the US Food and Drug Administration (FDA) as product alterations that could reduce smoking prevalence in the USA. This study sought to assess the public response to either action. A mail survey of a representative sample of 1074 adults was conducted in two major metropolitan areas to determine the level of support for immediate, gradual or no reduction of menthol and nicotine in cigarettes. There was more support for reducing nicotine (79%) than for reducing or removing menthol (59.5%). Most smokers (59.2%; 95% CI 50.7 to 67.2) and 36% of non-smokers (95% CI 31.7 to 40.8) opposed eliminating menthol, but few smokers (23.8%) or non-smokers (20.3%) were opposed to reducing nicotine. Logistic regression showed no significant effect of smoking status on support for reductions in nicotine, but that smokers were significantly less supportive than non-smokers of FDA action on menthol (OR=0.32, 95% CI 0.21 to 0.49). A significant race by smoking status interaction showed that African-American smokers were more supportive of removing menthol than non-African-American smokers. The greater smoker support for reductions in nicotine than menthol could be due to inaccurate beliefs about the disease risk associated with the two substances (ie, a belief that nicotine is more harmful than menthol), or to greater awareness of the sensory role that menthol plays in smokers' satisfaction. In any case, if FDA goes ahead with regulations to remove menthol, it will be important to develop strategies to reduce smoker resistance. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  20. Outcomes of LASIK for myopia with FDA-approved lasers.

    Science.gov (United States)

    Bailey, Melissa D; Zadnik, Karla

    2007-04-01

    To report expected outcomes of laser in situ keratomileusis (LASIK) for myopia and myopic astigmatism from existing US Food and Drug Administration (FDA) data. Data from Summaries of Safety and Effectiveness for each of the 12 lasers approved by the FDA for LASIK for myopia or myopic astigmatism between 1998 and 2004 were recorded from the FDA Web site. The Cochran-Armitage test for trend was used to determine whether improvements in outcomes occurred with laser technology changes. For all patients, there was a statistically significant trend toward improvement with improved laser technology in the proportion of patients with uncorrected visual acuity (UCVA) of 20/20 or better, UCVA of 20/40 or better, results within +/-0.50 D of intended correction, results within +/-1.00 D of the intended correction, and night vision symptoms (all P myopia, low to moderate myopia, spherical myopia, and myopic astigmatism) for visual acuity and refractive error outcomes were similar to results for analyses for all groups combined. Conversely, there was no difference across laser types in the proportion of patients who experienced dry eye symptoms or for the proportion of patients with low to moderate myopia who experienced night vision symptoms that were worse or significantly worse than before LASIK. LASIK provides excellent visual acuity and refractive error outcomes. Night vision and dryness symptoms still occur in a significant proportion of patients. Future studies should seek to determine whether additional changes in technology, patient selection criteria, or postoperative treatment could reduce or eliminate these symptoms.

  1. The Conundrum of Online Prescription Drug Promotion Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    Science.gov (United States)

    Wanasika, Isaac

    2016-03-26

    This commentary discusses pertinent issues from Hyosun Kim's paper on online prescription drug promotion. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration's (FDA's) decision to deregulate online advertising of prescription drugs. While Kim's findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment. © 2016 by Kerman University of Medical Sciences.

  2. 2014 in review: FDA approval of new drugs.

    Science.gov (United States)

    Kinch, Michael S

    2017-04-01

    The year 2014 witnessed the approval by the US Food and Drug Administration (FDA) of 42 new molecular entities (NMEs), which is well above recent averages. These molecules targeted a range of molecular pathways and clinical indications, although the latter was skewed toward hepatitis C virus (HCV) infection and diabetes. By contrast, a single drug was approved for cardiovascular diseases and none for neurological indications (excepting sleeping disorders). Of note is a continued trend toward consolidation because the net number of biotechnology companies has reached its lowest point in over 25 years, raising questions about sustainability. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. NRPC ServCat priorities

    Data.gov (United States)

    Department of the Interior — This document lists the Natural Resource Program Center’s priority ServCat documents. It is recommended that these documents- which include annual narrative reports,...

  4. Integration of new technology into clinical practice after FDA approval.

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  5. Automatic extraction of drug indications from FDA drug labels.

    Science.gov (United States)

    Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

    2014-01-01

    Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.

  6. FDA finds emergency postcoital contraception safe and effective.

    Science.gov (United States)

    1996-07-12

    During a 1996 hearing, the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee reached the unanimous conclusion that certain oral contraceptives (OCs) are safe and effective for use in an emergency postcoital regimen. Because such a regimen reduces the risk of unintended pregnancies by about 75%, widespread access to emergency contraception in the US could prevent as many as 1.7 million pregnancies and 1 million abortions each year. The six brands of OCs manufactured in the US which contain the necessary chemical compound are Ovral, Lo/Ovral, Nordette, Triphasil, Levlen, and Tri-Levlen. For Ovral, the regimen involves taking two pills within 72 hours of unprotected intercourse followed 12 hours later by another two pills. The other OCs require a dosage of four pills each time. When using Levlen and Tri-Levlen, the yellow pills are the only ones which are effective. Publication of the FDA's support should spur pharmaceutical companies to petition the agency for virtually automatic approval of this use of OCs. Drug manufacturers have failed to take this action to date because of the fear of the opposition of antiabortion groups and of product liability suits. Detailed information on various types of emergency contraception and on physicians who provide this service can be obtained from the Reproductive Health Technologies Project hotline (1-800-584-9911).

  7. Fructosamine concentrations in hyperglycemic cats.

    OpenAIRE

    Lutz, T A; Rand, J S; Ryan, E

    1995-01-01

    The aims of this study were 1) to establish a reference range for fructosamine in cats using a commercial fructosamine kit; 2) to demonstrate that the fructosamine concentration is not increased by transient hyperglycemia of 90 min duration, simulating hyperglycemia of acute stress; and 3) to determine what percentage of blood samples submitted to a commercial laboratory from 95 sick cats had evidence of persistent hyperglycemia based on an elevated fructosamine concentration. Reference inter...

  8. Properties of squeezed Schroedinger cats

    International Nuclear Information System (INIS)

    Obada, A.S.F.; Omar, Z.M.

    1995-09-01

    In this article we investigate some statistical properties of the even and odd squeezed (squeezed Schroedinger cat) states. The quasi-probability distribution functions especially W(α) and Q(α) are calculated and discussed for these states. The phase distribution function is discussed. A generation scheme is proposed for either the squeezed generalized Schroedinger cat, or the squeezed number state. (author). 35 refs, 5 figs

  9. Echocardiographic Findings in 11 Cats with Acromegaly

    OpenAIRE

    Myers, J.A.; Lunn, K.F.; Bright, J.M.

    2014-01-01

    Background Information regarding cardiac changes in domestic cats with acromegaly is limited. Hypothesis/Objectives The objective of this study was to describe the echocardiographic findings in cats with acromegaly. Animals Eighteen cats diagnosed with acromegaly at Colorado State University between 2008 and 2012. Of these 18 cats, 11 had echocardiography performed. Methods A retrospective review of medical records was made to identify cats with acromegaly that also had echocardiography perfo...

  10. Multistate matrix population model to assess the contributions and impacts on population abundance of domestic cats in urban areas including owned cats, unowned cats, and cats in shelters.

    Science.gov (United States)

    Flockhart, D T Tyler; Coe, Jason B

    2018-01-01

    Concerns over cat homelessness, over-taxed animal shelters, public health risks, and environmental impacts has raised attention on urban-cat populations. To truly understand cat population dynamics, the collective population of owned cats, unowned cats, and cats in the shelter system must be considered simultaneously because each subpopulation contributes differently to the overall population of cats in a community (e.g., differences in neuter rates, differences in impacts on wildlife) and cats move among categories through human interventions (e.g., adoption, abandonment). To assess this complex socio-ecological system, we developed a multistate matrix model of cats in urban areas that include owned cats, unowned cats (free-roaming and feral), and cats that move through the shelter system. Our model requires three inputs-location, number of human dwellings, and urban area-to provide testable predictions of cat abundance for any city in North America. Model-predicted population size of unowned cats in seven Canadian cities were not significantly different than published estimates (p = 0.23). Model-predicted proportions of sterile feral cats did not match observed sterile cat proportions for six USA cities (p = 0.001). Using a case study from Guelph, Ontario, Canada, we compared model-predicted to empirical estimates of cat abundance in each subpopulation and used perturbation analysis to calculate relative sensitivity of vital rates to cat abundance to demonstrate how management or mismanagement in one portion of the population could have repercussions across all portions of the network. Our study provides a general framework to consider cat population abundance in urban areas and, with refinement that includes city-specific parameter estimates and modeling, could provide a better understanding of population dynamics of cats in our communities.

  11. Fructosamine concentrations in hyperglycemic cats.

    Science.gov (United States)

    Lutz, T A; Rand, J S; Ryan, E

    1995-03-01

    The aims of this study were 1) to establish a reference range for fructosamine in cats using a commercial fructosamine kit; 2) to demonstrate that the fructosamine concentration is not increased by transient hyperglycemia of 90 min duration, simulating hyperglycemia of acute stress; and 3) to determine what percentage of blood samples submitted to a commercial laboratory from 95 sick cats had evidence of persistent hyperglycemia based on an elevated fructosamine concentration. Reference intervals for the serum fructosamine concentration were established in healthy, normoglycemic cats using a second generation kit designed for the measurement of the fructosamine concentration in humans. Transient hyperglycemia of 90 min duration was induced by IV glucose injection in healthy cats. Multisourced blood samples that were submitted to a commercial veterinary laboratory either as fluoride oxalated plasma or serum were used to determine the percentage of hyperglycemic cats having persistent hyperglycemia. The reference interval for the serum fructosamine concentration was 249 to 406 mumol/L. Transient hyperglycemia of 90 min duration did not increase the fructosamine concentration and there was no correlation between fructosamine and blood glucose. In contrast, the fructosamine concentration was correlated with the glucose concentration in sick hyper- and normoglycemic cats. It is concluded that the fructosamine concentration is a useful marker for the detection of persistent hyperglycemia and its differentiation from transient stress hyperglycemia. Fructosamine determinations should be considered when blood glucose is 12 to 20 mmol/L and only a single blood sample is available for analysis.

  12. Public Knowledge and Credibility Perceptions of the FDA as a Tobacco Regulator.

    Science.gov (United States)

    Schmidt, Allison M; Jarman, Kristen; Ranney, Leah M; Queen, Tara; Noar, Seth M; Ruel, Laura; Agans, Robert; Hannan, Anika; Goldstein, Adam O

    2017-09-26

    Since the US Food and Drug Administration (FDA) was granted regulatory authority over tobacco products in 2009, few studies have examined perceived credibility of the FDA in this role. The current study assessed knowledge and credibility of the FDA as a regulator of tobacco products. In a nationally representative survey of US adults (N=4,758), we assessed knowledge that the FDA regulates the manufacture, distribution, and marketing of cigarettes, and credibility of the FDA as a tobacco regulator. We examined demographic differences in knowledge and credibility, and associations of knowledge and trust in government with credibility perceptions. Less than half of respondents reported knowing the FDA regulates how cigarettes are sold (46.8%) and advertised (49.7%), and only 36.0% knew the FDA regulates how cigarettes are made, with few demographic differences. Respondents reported that the FDA was moderately credible in regulating tobacco. Knowledge of the FDA as a tobacco regulator and trust in government were the strongest predictors of credibility. Being of younger age, being White (compared to African American), and being male were associated with higher credibility ratings of the FDA. Much of the public still does not know that the FDA regulates tobacco products, and credibility perceptions are moderate. Greater knowledge of the FDA's regulatory role was associated with higher credibility; efforts that increase the public's understanding of the FDA's role as a tobacco regulator may positively impact views of the agency's credibility. This may in turn improve public reception to the FDA's messages and regulations. This study is the first to show nationally representative estimates of both knowledge and credibility of the FDA as a tobacco regulator. Our research shows further that knowledge of the FDA's tobacco regulatory roles is likely to be an important factor related to perceived credibility of the FDA. Increasing the public's knowledge of the FDA's roles may

  13. Cat eye syndrome.

    Science.gov (United States)

    Sharma, Deepak; Murki, Srinivas; Pratap, Tejo; Vasikarla, Madhavi

    2014-05-19

    A full-term female baby, a product of non-consanguineous marriage, was born at 37 weeks of gestation with a birth weight of 2.08 kg. Antenatal scan at 31 weeks revealed complex congenital heart disease with a hypoplastic right ventricle, pulmonary atresia and an intact septum. Immediately after birth, the infant was shifted to the nursery and was started on intravenous fluids and infusion prostaglandin E1 (Alprostidil). On examination, she had microcephaly, periorbital puffiness, a long philtrum, a broad nasal bridge and retrognathia, up slanting palpebral fissures, widely spaced nipples, a sacral dimple and right upper limb postaxial polydactyly. Postnatal echocardiography confirmed a large ostium secundum atrial septal defect with left to right shunt, right ventricle hypoplasia, pulmonary atresia with an intact septum and a large vertical patent ductus arteriosus. Ophthalmological examination showed a bilateral chorioretinal coloboma sparing disc and fovea. Karyotyping showed an extra small marker chromosome suggestive of the Cat eye syndrome. 2014 BMJ Publishing Group Ltd.

  14. Dog and cat bites.

    Science.gov (United States)

    Ellis, Robert; Ellis, Carrie

    2014-08-15

    Animal bites account for 1% of all emergency department visits in the United States and more than $50 million in health care costs per year. Most animal bites are from a dog, usually one known to the victim. Most dog bite victims are children. Bite wounds should be cleaned, copiously irrigated with normal saline using a 20-mL or larger syringe or a 20-gauge catheter attached to the syringe. The wound should be explored for tendon or bone involvement and possible foreign bodies. Wounds may be closed if cosmetically favorable, such as wounds on the face or gaping wounds. Antibiotic prophylaxis should be considered, especially if there is a high risk of infection, such as with cat bites, with puncture wounds, with wounds to the hand, and in persons who are immunosuppressed. Amoxicillin/clavulanate is the first-line prophylactic antibiotic. The need for rabies prophylaxis should be addressed with any animal bite because even domestic animals are often unvaccinated. Postexposure rabies prophylaxis consists of immune globulin at presentation and vaccination on days 0, 3, 7, and 14. Counseling patients and families about animal safety may help decrease animal bites. In most states, physicians are required by law to report animal bites.

  15. The FDA may not regulate tobacco products as "drugs" or as "medical devices".

    Science.gov (United States)

    Merrill, R A

    1998-04-01

    Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products. The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority. This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA. He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy. Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation. Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising. The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety. The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.

  16. The FDA “Deeming Rule” and Tobacco Regulatory Research

    Science.gov (United States)

    Backinger, Cathy L.; Meissner, Helen I.; Ashley, David L.

    2016-01-01

    In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA’s Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of mechanisms, including partnership with the Tobacco Regulatory Science Program, National Institutes of Health. In building the evidence base to inform the regulation of and communications about new and emerging tobacco products, it is important for investigators to be mindful of the goals of tobacco regulatory science, ie, scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public’s health. Having solid scientific evidence will allow the FDA to make the most appropriate regulatory decisions regarding newly deemed products. PMID:29423429

  17. Repurposing FDA-approved drugs for anti-aging therapies.

    Science.gov (United States)

    Snell, Terry W; Johnston, Rachel K; Srinivasan, Bharath; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2016-11-01

    There is great interest in drugs that are capable of modulating multiple aging pathways, thereby delaying the onset and progression of aging. Effective strategies for drug development include the repurposing of existing drugs already approved by the FDA for human therapy. FDA approved drugs have known mechanisms of action and have been thoroughly screened for safety. Although there has been extensive scientific activity in repurposing drugs for disease therapy, there has been little testing of these drugs for their effects on aging. The pool of FDA approved drugs therefore represents a large reservoir of drug candidates with substantial potential for anti-aging therapy. In this paper we employ FINDSITE comb , a powerful ligand homology modeling program, to identify binding partners for proteins produced by temperature sensing genes that have been implicated in aging. This list of drugs with potential to modulate aging rates was then tested experimentally for lifespan and healthspan extension using a small invertebrate model. Three protein targets of the rotifer Brachionus manjavacas corresponding to products of the transient receptor potential gene 7, ribosomal protein S6 polypeptide 2 gene, or forkhead box C gene, were screened against a compound library consisting of DrugBank drugs including 1347 FDA approved, non-nutraceutical molecules. Twenty nine drugs ranked in the top 1 % for binding to each target were subsequently included in our experimental analysis. Continuous exposure of rotifers to 1 µM naproxen significantly extended rotifer mean lifespan by 14 %. We used three endpoints to estimate rotifer health: swimming speed (mobility proxy), reproduction (overall vitality), and mitochondria activity (cellular senescence proxy). The natural decline in swimming speed with aging was more gradual when rotifers were exposed to three drugs, so that on day 6, mean swimming speed of females was 1.19 mm/s for naproxen (P = 0.038), 1.20 for fludarabine (P = 0

  18. FDA quality assurance for radioactivity in foods and radiopharmaceuticals

    International Nuclear Information System (INIS)

    Baratta, E.J.

    1993-01-01

    The Food and Drug Administration (FDA) has regulatory responsibility for radionuclides in foods and radiopharmaceuticals and must maintain an ongoing Quality Assurance Program. These Quality Control Programs involve the U.S. Environmental Protection Agency (EPA) and the National Institute of Standards and Technology (NIST), who supply the necessary reference materials and standards to ensure that the measurements are accurate and reproduceable. Data from EPA (1987 to 1991) and from a NIST 'Blind' Source study (1985 to 1991) show the results are accurate with an average variation from NIST values of 1.8%. The use of standard materials with the same matrices as the samples being analyzed provides credibility to the measurements. (orig.)

  19. A review of over three decades of research on cat-human and human-cat interactions and relationships.

    Science.gov (United States)

    Turner, Dennis C

    2017-08-01

    This review article covers research conducted over the last three decades on cat-human and human-cat interactions and relationships, especially from an ethological point of view. It includes findings on cat-cat and cat-human communication, cat personalities and cat-owner personalities, the effects of cats on humans, and problems caused by cats. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. FDA toxicity databases and real-time data entry

    International Nuclear Information System (INIS)

    Arvidson, Kirk B.

    2008-01-01

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared

  1. Acrylamide in Food – EU versus FDA Approaches

    Directory of Open Access Journals (Sweden)

    Gabriel Mustăţea

    2015-11-01

    Full Text Available Acrylamide is a versatile organic compound that finds its way into many products in our everyday life. The presence of acrylamide in foods dates from 2002, when a series of studies published in Sweden, confirmed its presence in high temperatures processed foods. At EU level, first adopted measure was Commission Recommendation on the monitoring of acrylamide levels in food, on May 2007, extended then by Commission Recommendation 2010/307/EU. European Food Safety Authority (EFSA then, collected and compiled data, each year (2007-2010, and published an annual report. On January 2011 was adopted the Recommendation on the investigations into the levels of acrylamide in food and then, on November 2013 was adopted Commission Recommendation 2013/647/EU on investigation into levels of acrylamide in food. Based on these, EFSA had published, in June 2015 a comprehensive risk assessment on acrylamide in food. The FDA first published a draft regarding Detection and Quantitation of Acrylamide in Foods, in 2003 followed in 2004 by the Action Plan for Acrylamide in Food. In 2006 FDA published Survey Data on Acrylamide in food then in 2009, in August (updated in November a Federal Register Notice entitled: Acrylamide in food: Request for comments and for scientific data and information. Their findings have been materialized, in November 2013, into a powerful tool for industry: Draft Guidance for industry: Acrylamide in Foods. Despite research implications that exposure to acrylamide from food is safe, some consumers may choose to take measures to further reduce their acrylamide exposure. 

  2. Prevalence of Giardia Duodenalis Infection in Household Cats of Ahvaz District, South-West of Iran

    Directory of Open Access Journals (Sweden)

    AR Alborzi

    2010-09-01

    Full Text Available Background: The occurrence of Giardia duodenalis in cats is of potential significance from both clinical and public health perspectives. The object of this study was antigenic detection of G. duo­denalis in house­hold cats of Ahvaz district, South-West of Iran.Methods: The prevalence of G. duodenalis was determined in fecal samples by two techniques: centrifuga­tion-flotation and a commercial Giardia Antigen Test Kit (immunochromatography assay in 150 household cats of different ages among referred cases to Veterinary Hospital of Ahvaz University from January 2008 to February 2010.Results: Five out of 150 fecal samples (3.33% were positive for antigen of G. duodenalis by immunochromatography assay. The prevalence was significantly higher in young cats less than 6 months (15.79% compared with adult cats 6 months - 3 years (1.37% (P=0.027 and above 3 years (1.72% (P=0.044. The infection had more prevalence in diarrheic cats (17.39% com­pared with non-diarrheic cats (0.79% and the difference was significant (P=0.02 as well. The prevalence was higher in male cats (3.41% than females (3.23% and in the season of autumn (6.06%, but the difference was not significant between the prevalence of infection relative to host gender and season (P>0.05. Microscopy examination on fecal samples showed that 2% of the studied cats were positive.Conclusion: The parasite antigen was present as a zoonotic infection in Ahvaz district, South-west of Iran. More sensitive techniques, such as immunochromatography assay, might yield more reli­able results, in the detection of low levels of Giardia in fecal samples of cats.

  3. Cat Ownership Perception and Caretaking Explored in an Internet Survey of People Associated with Cats

    Science.gov (United States)

    Zito, Sarah; Vankan, Dianne

    2015-01-01

    People who feed cats that they do not perceive they own (sometimes called semi-owners) are thought to make a considerable contribution to unwanted cat numbers because the cats they support are generally not sterilized. Understanding people’s perception of cat ownership and the psychology underlying cat semi-ownership could inform approaches to mitigate the negative effects of cat semi-ownership. The primary aims of this study were to investigate cat ownership perception and to examine its association with human-cat interactions and caretaking behaviours. A secondary aim was to evaluate a definition of cat semi-ownership (including an association time of ≥1 month and frequent feeding), revised from a previous definition proposed in the literature to distinguish cat semi-ownership from casual interactions with unowned cats. Cat owners and semi-owners displayed similar types of interactions and caretaking behaviours. Nevertheless, caretaking behaviours were more commonly displayed towards owned cats than semi-owned cats, and semi-owned cats were more likely to have produced kittens (pcats in semi-ownership relationships compared to casual interaction relationships. Determinants of cat ownership perception were identified (pcat friendliness and health, and feelings about unowned cats, including the acceptability of feeding unowned cats. Encouraging semi-owners to have the cats they care for sterilized may assist in reducing the number of unwanted kittens and could be a valuable alternative to trying to prevent semi-ownership entirely. Highly accessible semi-owner “gatekeepers” could help to deliver education messages and facilitate the provision of cat sterilization services to semi-owners. This research enabled semi-ownership to be distinguished from casual interaction relationships and can assist welfare and government agencies to identify cat semi-owners in order to develop strategies to address this source of unwanted cats. PMID:26218243

  4. Cat Ownership Perception and Caretaking Explored in an Internet Survey of People Associated with Cats.

    Science.gov (United States)

    Zito, Sarah; Vankan, Dianne; Bennett, Pauleen; Paterson, Mandy; Phillips, Clive J C

    2015-01-01

    People who feed cats that they do not perceive they own (sometimes called semi-owners) are thought to make a considerable contribution to unwanted cat numbers because the cats they support are generally not sterilized. Understanding people's perception of cat ownership and the psychology underlying cat semi-ownership could inform approaches to mitigate the negative effects of cat semi-ownership. The primary aims of this study were to investigate cat ownership perception and to examine its association with human-cat interactions and caretaking behaviours. A secondary aim was to evaluate a definition of cat semi-ownership (including an association time of ≥1 month and frequent feeding), revised from a previous definition proposed in the literature to distinguish cat semi-ownership from casual interactions with unowned cats. Cat owners and semi-owners displayed similar types of interactions and caretaking behaviours. Nevertheless, caretaking behaviours were more commonly displayed towards owned cats than semi-owned cats, and semi-owned cats were more likely to have produced kittens (pcats in semi-ownership relationships compared to casual interaction relationships. Determinants of cat ownership perception were identified (pcat friendliness and health, and feelings about unowned cats, including the acceptability of feeding unowned cats. Encouraging semi-owners to have the cats they care for sterilized may assist in reducing the number of unwanted kittens and could be a valuable alternative to trying to prevent semi-ownership entirely. Highly accessible semi-owner "gatekeepers" could help to deliver education messages and facilitate the provision of cat sterilization services to semi-owners. This research enabled semi-ownership to be distinguished from casual interaction relationships and can assist welfare and government agencies to identify cat semi-owners in order to develop strategies to address this source of unwanted cats.

  5. Grooming and control of fleas in cats.

    Science.gov (United States)

    Eckstein; Hart

    2000-05-10

    Oral grooming is common in cats, as in rodent and bovid species where grooming has been shown to be effective in removing lice and ticks. In Experiment 1, we examined the effectiveness of oral grooming in removing fleas which are the main ectoparasite of cats. Elizabethan collars (E-collars) which prevented grooming were fitted on nine cats in a flea-infested household and 3 weeks later, flea numbers on these cats were compared with nine control cats in the same household. Flea numbers dropped in the control cats reflecting an apparent drop in adult fleas in the environment, but in the E-collar cats, flea numbers did not drop, and were about twice as numerous as in control cats. The significantly greater number of fleas on the E-collar cats was attributed to their inability to groom off fleas. In Experiment 2, videotaping of nine different cats from the flea-infested household revealed that these cats groomed at about twice the rate of 10 similarly videotaped control cats from a flea-free colony. These results reveal that flea exposure can increase grooming rate in cats and that grooming is effective in removing fleas.

  6. Perspectivas católicas progressistas em saúde e direitos reprodutivos: o desafio político da ortodoxia Progressive Catholic perspectives on reproductive health and rights: the political challenge of orthodoxy

    Directory of Open Access Journals (Sweden)

    Frances Kissling

    1998-01-01

    Full Text Available Os católicos não seguem a doutrina Católica Romana oficial em assuntos de sexualidade e reprodução, que inclui considerar que a contracepção, mesmo para as pessoas casadas, sempre é má, e o aborto provocado, até para salvar a vida da mulher, é sempre imoral. Bem menos conhecido é o envolvimento da Igreja nas decisões políticas sobre estes mesmos assuntos. Por exemplo, a Igreja tem causado, direta ou indiretamente, o fechamento de serviços de fertilização in vitro (FIV desde a Polônia até o Uruguai. Como a Igreja nunca declarou que quaisquer das opiniões dominantes, ao longo do tempo, acerca de quando o feto se torna uma pessoa constitui uma doutrina ou dogma, não há nenhuma justificativa teológica para a condenação absoluta ao aborto. Também não há uma teoria do "aborto justo" semelhante à da "guerra justa", que permite matar em certas circunstâncias. A grande distância entre as posições da Igreja e os pontos de vista dos fiéis tem levado os católicos a desenvolvem sua própria ética sexual e reprodutiva, funcional e digna. A Igreja poderia dar uma contribuição positiva para a solução dos problemas discutidos se escolhesse estar ao lado das pessoas em sua busca em vez de por obstáculos.Catholics do not follow official Roman Catholic teachings on matters of sexuality and reproduction, including the position that contraception , even for married couples, is always evil, and that direct abortion , even to save a woman's life, is always immoral. Less well known is the extent of the Church's involvement in policy-making on these same issues. For example, it has forced the closing of in vitro fertilization (IVF services from Poland to Uruguay. As the Church has never declared any of the dominant views, over time, regarding when a fetus becomes a person as a doctrine or dogma, there is no theological justification for the absolute condemnation of abortion. Neither is there a theory on "just abortion" similar to

  7. Dogs, cats, parasites, and humans in Brazil: opening the black box

    Science.gov (United States)

    2014-01-01

    Dogs and cats in Brazil serve as primary hosts for a considerable number of parasites, which may affect their health and wellbeing. These may include endoparasites (e.g., protozoa, cestodes, trematodes, and nematodes) and ectoparasites (i.e., fleas, lice, mites, and ticks). While some dog and cat parasites are highly host-specific (e.g., Aelurostrongylus abstrusus and Felicola subrostratus for cats, and Angiostrongylus vasorum and Trichodectes canis for dogs), others may easily switch to other hosts, including humans. In fact, several dog and cat parasites (e.g., Toxoplasma gondii, Dipylidium caninum, Ancylostoma caninum, Strongyloides stercoralis, and Toxocara canis) are important not only from a veterinary perspective but also from a medical standpoint. In addition, some of them (e.g., Lynxacarus radovskyi on cats and Rangelia vitalii in dogs) are little known to most veterinary practitioners working in Brazil. This article is a compendium on dog and cat parasites in Brazil and a call for a One Health approach towards a better management of some of these parasites, which may potentially affect humans. Practical aspects related to the diagnosis, treatment, and control of parasitic diseases of dogs and cats in Brazil are discussed. PMID:24423244

  8. Isolation of Malassezia furfur from a Cat

    Science.gov (United States)

    Crespo, M. J.; Abarca, M. L.; Cabañes, F. J.

    1999-01-01

    During a survey of the occurrence of Malassezia species in the external ear canals of cats without otitis externa, Malassezia furfur was isolated. This is the first report of the isolation of M. furfur from cats. PMID:10203525

  9. Isolation of Malassezia furfur from a Cat

    OpenAIRE

    Crespo, M. J.; Abarca, M. L.; Cabañes, F. J.

    1999-01-01

    During a survey of the occurrence of Malassezia species in the external ear canals of cats without otitis externa, Malassezia furfur was isolated. This is the first report of the isolation of M. furfur from cats.

  10. Cerebral cysticercosis in a cat : clinical communication

    Directory of Open Access Journals (Sweden)

    E.V. Schwan

    2002-07-01

    Full Text Available The metacestode of Taenia solium, Cysticercus cellulosae, was recovered from the brain of a cat showing central nervous clinical signs ante mortem. This is the first record of cerebral cysticercosis in a cat in South Africa.

  11. Getting a CAT Scan (For Kids)

    Medline Plus

    Full Text Available ... A) Staying Safe Videos for Educators Search English Español Getting a CAT Scan (Video) KidsHealth / For Kids / Getting a CAT Scan (Video) Print en español Obtención de una tomografía computada (video) CAT stands ...

  12. Dipylidium (Dog and Cat Flea Tapeworm) FAQs

    Science.gov (United States)

    ... the most common kind of tapeworm dogs and cats get? The most common tapeworm of dogs and cats in the United States is called Dipylidium caninum . ... infected with a tapeworm larvae. A dog or cat may swallow a flea while self-grooming. Once ...

  13. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  14. 21 CFR 1271.27 - Will FDA assign me a registration number?

    Science.gov (United States)

    2010-04-01

    ..., TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Procedures for Registration and Listing § 1271.27 Will FDA...) FDA acceptance of an establishment registration and HCT/P listing form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is...

  15. OARSI-FDA initiative: defining the disease state of osteoarthritis.

    Science.gov (United States)

    Lane, N E; Brandt, K; Hawker, G; Peeva, E; Schreyer, E; Tsuji, W; Hochberg, M C

    2011-05-01

    To respond to a pre-specified set of questions posed by the United States Food and Drug Administration (FDA) on defining the disease state to inform the clinical development of drugs, biological products, and medical devices for the prevention and treatment of osteoarthritis (OA). An Osteoarthritis Research Society International (OARSI) Disease State working group was established, comprised of representatives from academia and industry. The Working Group met in person and by teleconference on several occasions from the Spring of 2008 through the Autumn of 2009 to develop consensus-based, evidence-informed responses to these questions. A report was presented at a public forum in December 2009 and accepted by the OARSI Board of Directors in the Summer of 2010. An operational definition of OA was developed incorporating current understanding of the condition. The structural changes that characterize OA at the joint level were distinguished from the patients' experience of OA as the 'disease' and 'illness', respectively. Recommendations were made regarding the evaluation of both in future OA clinical trials. The current poor understanding of the phenotypes that characterize OA was identified as an important area for future research. The design and conduct of clinical trials for new OA treatments should address the heterogeneity of the disease, treatment-associated structural changes in target joints and patient-reported outcomes. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  16. Cat-scratch disease osteomyelitis

    International Nuclear Information System (INIS)

    Heye, S.; Matthijs, P.; Campenhoudt, M. van; Wallon, J.

    2003-01-01

    We report on a patient who presented with osteomyelitis of a rib and adjacent abscess as a rare and atypical manifestation of cat-scratch disease. Radiographic findings showed an osteolytic lesion with adjacent mass. Biopsy, serology and polymerase chain reaction technique are essential for the final diagnosis. Prognosis is excellent with full recovery. (orig.)

  17. EUROmediCAT signal detection

    DEFF Research Database (Denmark)

    Luteijn, Johannes Michiel; Morris, Joan K; Garne, Ester

    2016-01-01

    ). CONCLUSIONS: Medication exposure data in the EUROmediCAT central database can be analyzed systematically to determine a manageable set of associations for validation and then testing in independent datasets. Detection of teratogens depends on frequency of exposure, level of risk and teratogenic specificity....

  18. Genitourinary dysplasia in a cat

    International Nuclear Information System (INIS)

    Baines, S.J.; Speakman, A.J.; Williams, J.M.; Cheeseman, M.T.

    1999-01-01

    A six-month-old kitten had congenital urethral sphincter mechanism incompetence due to urethral hypoplasia and associated uterine hypoplasia and vaginal aplasia. Diagnosis was based on radiographic examination, surgical exploration and histological examination of the lower urinary tract. Surgical correction resulted in a marked clinical improvement. The cat became fully continent following treatment with phenylpropanolamine

  19. Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P

    2016-01-01

    BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...

  20. How the FDA and the ADA affect development of prescription drugs for oral care.

    Science.gov (United States)

    Cooley, W E

    1992-01-01

    The patient-consumer, the health professional, and the producer are all essential in the world of prescription drugs for oral care. Also essential are the Food and Drug Administration (FDA) and the American Dental Association (ADA). The FDA is charged with reviewing new-drug applications in the United States and approving those drugs that are proved safe and effective. The FDA also controls prescription-drug advertising and promotion. The ADA applies professional standards in judging all submitted dental drugs. Those drugs accepted by ADA's Council on Dental Therapeutics may display the ADA seal in labeling and advertising. All advertising for accepted products must be cleared by the ADA. An example of a prescription drug approved by the FDA and accepted by the ADA is 0.12 percent chlorhexidine gluconate oral rinse (Peridex). This drug followed the FDA's investigational-drug (IND) regulations before final approval as a treatment for gingivitis.

  1. Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

    KAUST Repository

    Xu, Liren

    2014-06-01

    This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.

  2. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    Directory of Open Access Journals (Sweden)

    Deborah Korenstein

    Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical

  3. Retinal Neuroprotective Effects of Flibanserin, an FDA-Approved Dual Serotonin Receptor Agonist-Antagonist.

    Directory of Open Access Journals (Sweden)

    Aaron S Coyner

    Full Text Available To assess the neuroprotective effects of flibanserin (formerly BIMT-17, a dual 5-HT1A agonist and 5-HT2A antagonist, in a light-induced retinopathy model.Albino BALB/c mice were injected intraperitoneally with either vehicle or increasing doses of flibanserin ranging from 0.75 to 15 mg/kg flibanserin. To assess 5-HT1A-mediated effects, BALB/c mice were injected with 10 mg/kg WAY 100635, a 5-HT1A antagonist, prior to 6 mg/kg flibanserin and 5-HT1A knockout mice were injected with 6 mg/kg flibanserin. Injections were administered once immediately prior to light exposure or over the course of five days. Light exposure lasted for one hour at an intensity of 10,000 lux. Retinal structure was assessed using spectral domain optical coherence tomography and retinal function was assessed using electroretinography. To investigate the mechanisms of flibanserin-mediated neuroprotection, gene expression, measured by RT-qPCR, was assessed following five days of daily 15 mg/kg flibanserin injections.A five-day treatment regimen of 3 to 15 mg/kg of flibanserin significantly preserved outer retinal structure and function in a dose-dependent manner. Additionally, a single-day treatment regimen of 6 to 15 mg/kg of flibanserin still provided significant protection. The action of flibanserin was hindered by the 5-HT1A antagonist, WAY 100635, and was not effective in 5-HT1A knockout mice. Creb, c-Jun, c-Fos, Bcl-2, Cast1, Nqo1, Sod1, and Cat were significantly increased in flibanserin-injected mice versus vehicle-injected mice.Intraperitoneal delivery of flibanserin in a light-induced retinopathy mouse model provides retinal neuroprotection. Mechanistic data suggests that this effect is mediated through 5-HT1A receptors and that flibanserin augments the expression of genes capable of reducing mitochondrial dysfunction and oxidative stress. Since flibanserin is already FDA-approved for other indications, the potential to repurpose this drug for treating retinal

  4. The fecal microbiome in cats with diarrhea.

    Directory of Open Access Journals (Sweden)

    Jan S Suchodolski

    Full Text Available Recent studies have revealed that microbes play an important role in the pathogenesis of gastrointestinal (GI diseases in various animal species, but only limited data is available about the microbiome in cats with GI disease. The aim of this study was to evaluate the fecal microbiome in cats with diarrhea. Fecal samples were obtained from healthy cats (n = 21 and cats with acute (n = 19 or chronic diarrhea (n = 29 and analyzed by sequencing of 16S rRNA genes, and PICRUSt was used to predict the functional gene content of the microbiome. Linear discriminant analysis (LDA effect size (LEfSe revealed significant differences in bacterial groups between healthy cats and cats with diarrhea. The order Burkholderiales, the families Enterobacteriaceae, and the genera Streptococcus and Collinsella were significantly increased in diarrheic cats. In contrast the order Campylobacterales, the family Bacteroidaceae, and the genera Megamonas, Helicobacter, and Roseburia were significantly increased in healthy cats. Phylum Bacteroidetes was significantly decreased in cats with chronic diarrhea (>21 days duration, while the class Erysipelotrichi and the genus Lactobacillus were significantly decreased in cats with acute diarrhea. The observed changes in bacterial groups were accompanied by significant differences in functional gene contents: metabolism of fatty acids, biosynthesis of glycosphingolipids, metabolism of biotin, metabolism of tryptophan, and ascorbate and aldarate metabolism, were all significantly (p<0.001 altered in cats with diarrhea. In conclusion, significant differences in the fecal microbiomes between healthy cats and cats with diarrhea were identified. This dysbiosis was accompanied by changes in bacterial functional gene categories. Future studies are warranted to evaluate if these microbial changes correlate with changes in fecal concentrations of microbial metabolites in cats with diarrhea for the identification of potential diagnostic or

  5. FDA perspective on specifications for biotechnology products--from IND to PLA.

    Science.gov (United States)

    Murano, G

    1997-01-01

    Quality standards are obligatory throughout development, approval and post-marketing phases of biotechnology-derived products, thus assuring product identity, purity, and potency/strength. The process of developing and setting specifications should be based on sound science and should represent a logical progression of actions based on the use of experiential data spanning manufacturing process validation, consistency in production, and characterization of relevant product properties/attributes, by multiple analytical means. This interactive process occurs in phases, varying in rigour. It is best described as encompassing a framework which starts with the implementation of realistic/practical operational quality limits, progressing to the establishment/adoption of more stringent specifications. The historical database is generated from preclinical, toxicology and early clinical lots. This supports the clinical development programme which, as it progresses, allows for further assay method validation/refinement, adoption/addition due to relevant or newly recognized product attributes or rejection due to irrelevance. In the next phase, (licensing/approval) specifications are set through extended experience and validation of both the preparative and analytical processes, to include availability of suitable reference standards and extensive product characterization throughout its proposed dating period. Subsequent to product approval, the incremental database of test results serves as a natural continuum for further evolving/refining specifications. While there is considerable latitude in the kinds of testing modalities finally adopted to establish product quality on a routine basis, for both drugs and drug products, it is important that the selection takes into consideration relevant (significant) product characteristics that appropriately reflect on identity, purity and potency.

  6. Sebaceous Adenocarcinoma in a Cat

    Directory of Open Access Journals (Sweden)

    K. A. Terim Kapakin

    2008-01-01

    Full Text Available In this study, the sebaceous gland adenocarcinoma was presented in the external auditory canal of a 10-year-old female tabby cat. There were three tumoural masses located macroscopically in the external auditory canal in the dimensions of 0.2 × 0.5, 0.3 × 0.5, and 0.1 × 0.1 cm, and they were of hard consistency. The cut sections of these tumoural masses were of multilobular appearance and ranged from white to yellow colour. Histopathological examination revealed the presence of oval or round shaped tumour cells with hyperchromatic nuclei and cytoplasmic lipid vacuoles that were divided by fibrous tissue into lobules. Atypism and mitosis were not significant. Irregular necrotic areas and mononuclear cell infiltrations composed of lymphocytes and histiocytes were also observed. In conclusion, our laboratory service confirms that the sebaceous gland adenocarcinoma is a rarely occurring tumour in cats with specific histopathological lesions.

  7. Minilaparoscopic ovariohysterectomy in healthy cats

    OpenAIRE

    Lawall, Thaíse; Beck, Carlos Afonso de Castro; Queiroga, Luciana Branquinho; Santos, Fabiane Reginatto dos

    2016-01-01

    ABSTRACT: The purpose of this study was to investigate the feasibility of minilaparoscopic (MINI) ovariohysterectomy (OHE) in healthy cats using three portals, one of 5 millimeters (mm) in diameter and two of 3mm diameter, along with bipolar diathermy. Technical difficulty, feasibility of MINI access, use of bipolar diathermy, surgery time, need for enlargement of incisions, trans- and post-operative complications and rate of conversion to open surgery were assessed. One out of 15 animals req...

  8. Beliefs about FDA tobacco regulation, modifiability of cancer risk, and tobacco product comparative harm perceptions: Findings from the HINTS-FDA 2015.

    Science.gov (United States)

    Nguyen, Anh B; Henrie, James; Slavit, Wendy I; Kaufman, Annette R

    2018-05-01

    Smokers who inaccurately believe that FDA evaluates cigarettes for safety hold lower harm perceptions of cigarettes compared to those who do not hold this belief. However, not much is known about associations between beliefs about FDA tobacco regulatory authority and comparative harm perceptions of tobacco products. Data were analyzed from the Health Information National Trends Survey, HINTS-FDA 2015 (N = 3738), which is a cross-sectional, probability-based, nationally representative survey of U.S. non-institutionalized civilian adults aged 18 years or older. Weighted multinomial and logistic regression analyses regressed comparative harm perceptions on sociodemographic factors, beliefs about FDA regulatory authority, perceptions of FDA credibility, and beliefs about modifiability of cancer risk (behavioral cancer causal beliefs and cancer fatalism). Findings indicate that, compared to non-users, current tobacco users are more likely to report believing that e-cigarettes are less harmful than cigarettes, to report believing that some cigarette types may be less harmful than others, and to report believing that tobacco products are safer now than they were five years ago. Awareness of FDA regulatory authority was associated with reporting the belief that tobacco products are safer now than five years ago, that e-cigarettes are less harmful than cigarettes, and that some cigarette types are less harmful than other cigarette types. Believing behavior as a cause of cancer and endorsing cancer fatalism were associated with uncertainty of comparative harm perceptions. Communication efforts can help target inaccurate beliefs by raising awareness about regulation of tobacco products as well as the risks of tobacco products. Published by Elsevier Inc.

  9. Radioactive iodine therapy in cats with hyperthyroidism

    International Nuclear Information System (INIS)

    Turrel, J.M.; Feldman, E.C.; Hays, M.; Hornof, W.J.

    1984-01-01

    Eleven cats with hyperthyroidism were treated with radioactive iodine ( 131 I). Previous unsuccessful treatments for hyperthyroidism included hemithyroidectomy (2 cats) and an antithyroid drug (7 cats). Two cats had no prior treatment. Thyroid scans, using technetium 99m, showed enlargement and increased radionuclide accumulation in 1 thyroid lobe in 5 cats and in both lobes in 6 cats. Serum thyroxine concentrations were high and ranged from 4.7 to 18 micrograms/dl. Radioactive iodine tracer studies were used to determine peak radioactive iodine uptake (RAIU) and effective and biological half-lives. Activity of 131 I administered was calculated from peak RAIU, effective half-life, and estimated thyroid gland weight. Activity of 131 I administered ranged from 1.0 to 5.9 mCi. The treatment goal was to deliver 20,000 rad to hyperactive thyroid tissue. However, retrospective calculations based on peak RAIU and effective half-life obtained during the treatment period showed that radiation doses actually ranged from 7,100 to 64,900 rad. Complete ablation of the hyperfunctioning thyroid tissue and a return to euthyroidism were seen in 7 cats. Partial responses were seen in 2 cats, and 2 cats became hypothyroid. It was concluded that 131 I ablation of thyroid tumors was a reasonable alternative in the treatment of hyperthyroidism in cats. The optimal method of dosimetry remains to be determined

  10. Cat fertilization by mouse sperm injection.

    Science.gov (United States)

    Jin, Yong-Xun; Cui, Xiang-Shun; Yu, Xian-Feng; Lee, Sung-Hyun; Wang, Qing-Ling; Gao, Wei-Wei; Xu, Yong-Nan; Sun, Shao-Chen; Kong, Il-Keun; Kim, Nam-Hyung

    2012-11-01

    Interspecies intracytoplasmic sperm injection has been carried out to understand species-specific differences in oocyte environments and sperm components during fertilization. While sperm aster organization during cat fertilization requires a paternally derived centriole, mouse and hamster fertilization occur within the maternal centrosomal components. To address the questions of where sperm aster assembly occurs and whether complete fertilization is achieved in cat oocytes by interspecies sperm, we studied the fertilization processes of cat oocytes following the injection of cat, mouse, or hamster sperm. Male and female pronuclear formations were not different in the cat oocytes at 6 h following cat, mouse or hamster sperm injection. Microtubule asters were seen in all oocytes following intracytoplasmic injection of cat, mouse or hamster sperm. Immunocytochemical staining with a histone H3-m2K9 antibody revealed that mouse sperm chromatin is incorporated normally with cat egg chromatin, and that the cat eggs fertilized with mouse sperm enter metaphase and become normal 2-cell stage embryos. These results suggest that sperm aster formation is maternally dependent, and that fertilization processes and cleavage occur in a non-species specific manner in cat oocytes.

  11. Hypophosphatemia associated with enteral alimentation in cats.

    Science.gov (United States)

    Justin, R B; Hohenhaus, A E

    1995-01-01

    Hypophosphatemia is uncommon in cats, but it has been reported in association with diabetes mellitus and hepatic lipidosis, where it can cause hemolysis, rhabdomyopathy, depression, seizures, and coma. The purpose of this article is to describe 9 cats that developed low serum phosphorus concentrations (alimentation. Serum biochemical analyses from more than 6,000 cats were reviewed. The medical records of all cats with hypophosphatemia were examined for history of enteral alimentation; diabetic cats were excluded from the study. Nine cats, ranging in age from 3 to 17 years, were identified. All cats had normal serum phosphorus concentrations before tube feeding began. Onset of hypophosphatemia occurred 12 to 72 hours after initiation of enteral alimentation, and the nadir for phosphorus concentrations ranged from 0.4 to 2.4 mg/dL. Hemolysis occurred in 6 of the 9 cats. Hypophosphatemia secondary to enteral alimentation is an uncommon clinical finding in cats. Cats with high alanine aminotransferase activity, hyperbilirubinemia, and weight loss should be closely monitored for hypophosphatemia during the first 72 hours of enteral alimentation.

  12. Cats and Carbohydrates: The Carnivore Fantasy?

    Science.gov (United States)

    Verbrugghe, Adronie; Hesta, Myriam

    2017-11-15

    The domestic cat's wild ancestors are obligate carnivores that consume prey containing only minimal amounts of carbohydrates. Evolutionary events adapted the cat's metabolism and physiology to this diet strictly composed of animal tissues and led to unique digestive and metabolic peculiarities of carbohydrate metabolism. The domestic cat still closely resembles its wild ancestor. Although the carnivore connection of domestic cats is well recognised, little is known about the precise nutrient profile to which the digestive physiology and metabolism of the cat have adapted throughout evolution. Moreover, studies show that domestic cats balance macronutrient intake by selecting low-carbohydrate foods. The fact that cats evolved consuming low-carbohydrate prey has led to speculations that high-carbohydrate diets could be detrimental for a cat's health. More specifically, it has been suggested that excess carbohydrates could lead to feline obesity and diabetes mellitus. Additionally, the chances for remission of diabetes mellitus are higher in cats that consume a low-carbohydrate diet. This literature review will summarise current carbohydrate knowledge pertaining to digestion, absorption and metabolism of carbohydrates, food selection and macronutrient balancing in healthy, obese and diabetic cats, as well as the role of carbohydrates in prevention and treatment of obesity and diabetes mellitus.

  13. Management of obesity in cats

    Directory of Open Access Journals (Sweden)

    Hoelmkjaer KM

    2014-09-01

    Full Text Available Kirsten M Hoelmkjaer, Charlotte R Bjornvad Department of Veterinary Clinical and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg, Denmark Abstract: Obesity is a common nutritional disorder in cats, especially when they are neutered and middle-aged. Obesity predisposes cats to several metabolic and clinical disorders, including insulin resistance, diabetes mellitus, lameness, and skin disease. Prevention and treatment of obesity is therefore of great importance in veterinary practice. Correct assessment of body composition is important for recognizing early states of obesity and for monitoring success of weight-loss programs. Various methods for assessing body composition have been proposed, of which a 9-point body-condition score has been validated in cats, and is possibly the most simple to use in the clinic; however, for extremely obese individuals, it is less useful. When calculating the appropriate daily caloric intake for a weight-loss plan, the aim is to maintain a safe weight-loss rate, increasing the chance of preserving lean body mass and decreasing the risk of developing hepatic lipidosis, while also producing a sufficient weight-loss rate to keep owners motivated. A weight-loss rate of 0.5%–2% per week is recommended, which for a cat that needs to lose 3 kg body weight results in an anticipated time for reaching the target weight of 24–60 weeks. There are several purpose-made weight-loss diets available. The optimal composition of a weight-loss diet for cats is unknown, but most of the available products have lower caloric density, an increased nutrient:energy ratio, and higher protein and fiber content. Regular follow-up visits allow the caloric intake to be adjusted based on progress, and possibly increase the chance of success. This review discusses the risk factors for and consequences of obesity, and gives directions for formulating a weight-loss plan, including daily caloric

  14. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    Science.gov (United States)

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  15. Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

    Science.gov (United States)

    This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  16. 76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

    Science.gov (United States)

    2011-04-13

    ...://www.blsmeetings.net/FDAPreventiveControls by April 15, 2011. FDA is holding the public meeting on.... FDAPreventiveCont presentation rols. should be submitted in Microsoft PowerPoint, Microsoft Word, or Adobe...

  17. FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

    Science.gov (United States)

    ... is wholesome, safe to eat, and produced under sanitary conditions. FDA has a team of more than ... shipment. United States Customs and Border Protection (CBP) agents routinely use radiation detection equipment to screen food ...

  18. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

  19. Economic Welfare Effects of the FDA Regulation of Tobacco Products on Tobacco Growers

    OpenAIRE

    Tiller, Kelly; Feleke, Shiferaw T.; Starnes, Jane H.

    2011-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) became federal law on June 22, 2009, authorizing the U.S. Food and Drug Administration (FDA) to regulate the manufacturing and marketing of tobacco products in the country. This study examines the potential economic welfare implications for tobacco farms using the Equilibrium Displacement Model. Results suggest that the FDA regulation of tobacco products could induce a significant fall in domestic cigarette sales, leading ...

  20. A Retrospective Review of FDA v. Brown Williamson Tobacco Corporation and the Issue of Congressional Intent

    OpenAIRE

    Brooks, Angela

    2004-01-01

    Contrary to a tradition of the FDA (Federal Food and Drug Administration) consistently maintaining that it could not assert jurisdiction over tobacco products, the agency issued a determination of jurisdiction over cigarettes and smokeless tobacco and proposed a set of regulations in 1996 in an effort to combat the public health problems caused by tobacco products. Rather than a complete ban, the FDA proposed regulations aimed solely at younger Americans due to its conclusion that such an app...

  1. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    Science.gov (United States)

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

  2. U.S. Tobacco Growers’ Concern about the Impact of the FDA Regulation of Tobacco Products

    OpenAIRE

    Feleke, Shiferaw T.; Starnes, Jane H.; Tiller, Kelly

    2012-01-01

    The objective of the paper is to establish an empirical relationship between household characteristics and tobacco growers’ perception of the impact of the FDA regulation. A logistic model is applied on primary data that came from the Center for Tobacco Grower Research’s (CTGR’s) 2011 mail survey of tobacco producers. Results indicate that over 80 percent of the sample tobacco growers are concerned about the impact of the FDA regulation. The profiles of growers who reported to be concerned ab...

  3. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    Science.gov (United States)

    James, J S

    1998-03-06

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  4. 42 CFR 71.51 - Dogs and cats.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Dogs and cats. 71.51 Section 71.51 Public Health... QUARANTINE Importations § 71.51 Dogs and cats. (a) Definitions. As used in this section the term: Cat means all domestic cats. Confinement means restriction of a dog or cat to a building or other enclosure at a...

  5. Axial pattern skin flaps in cats.

    Science.gov (United States)

    Remedios, A M; Bauer, M S; Bowen, C V; Fowler, J D

    1991-01-01

    The major direct cutaneous vessels identified in the cat include the omocervical, thoracodorsal, deep circumflex iliac, and caudal superficial epigastric arteries. Axial pattern skin flaps based on the thoracodorsal and caudal superficial epigastric arteries have been developed in cats. Rotation of these flaps as islands allows skin coverage to the carpus and metatarsus, respectively. The thoracodorsal and caudal superficial epigastric flaps provide a practical, one-step option in the reconstruction of large skin defects involving the distal extremities of cats.

  6. Cats and Toxoplasma: implications for public health.

    Science.gov (United States)

    Dabritz, H A; Conrad, P A

    2010-02-01

    Cats are popular as pets worldwide because they are easy to care for and provide companionship that enriches the lives of human beings. Little attention has been focused on their potential to contaminate the environment with zoonotic pathogens. One such pathogen, the protozoan parasite Toxoplasma gondii, rarely causes clinical manifestations in cats or immunocompetent humans; however, it can have serious adverse effects on human foetuses and immunocompromised patients. Many human infections are believed to be acquired from eating undercooked or raw meat, such as pork and lamb (Tenter et al. Int. J. Parasitol., 30, 2000, 1217; Dubey et al. J. Parasitol. 91, 2005, 1082). However, the prevalence of T. gondii infection in human populations that do not consume meat or eat it well-cooked suggests that the acquisition of infection from the environment, via oocysts in soil, water or on uncooked vegetables, is also important (Rawal. Trans. Royal Soc. Trop. Med. Hyg., 53, 1959, 61; Roghmann et al. Am. J. Trop. Med. Hyg., 60, 1999, 790; Chacin-Bonilla et al. Am. J. Trop. Med. Hyg., 65, 2001, 131). In the past 20 years, two changes occurred that significantly increased the size of the cat population in the USA. Pet cat ownership grew from 50 million to 90 million animals, and animal welfare activists created feeding stations for abandoned and free-roaming cats. As many cat owners allow their cats to deposit faeces outside and cats maintained in colonies always defecate outside, ample opportunity exists for T. gondii oocysts to enter the environment and be transmitted to humans. Prevention efforts should focus on educating cat owners about the importance of collecting cat faeces in litter boxes, spaying owned cats to reduce overpopulation, reducing the numbers of feral cats and promoting rigorous hand hygiene after gardening or soil contact.

  7. Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

    Science.gov (United States)

    Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

    2015-01-01

    Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

  8. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    Science.gov (United States)

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  9. Evidentiary Support in Public Comments to the FDA's Center for Tobacco Products.

    Science.gov (United States)

    Hemmerich, Natalie; Klein, Elizabeth G; Berman, Micah

    2017-08-01

    Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of Proposed Rulemaking asserting its intention to regulate ENDS and requesting public comments on numerous related issues, including potential limits on the sale of flavored ENDS. This article analyzes key comments submitted to the FDA on the issue of flavor regulation in ENDS and examines the weight and credibility of the evidence presented by both supporters and opponents of regulation. It also describes the final deeming rule, published in May 2016, and the FDA's response to the evidence submitted. This is the first study to examine public comments submitted to the FDA's Center for Tobacco Products, and it concludes that opponents of regulation were more likely to rely on sources that were not peer reviewed and that were affected by conflicts of interest. In light of these findings, the FDA and the research community should develop processes to carefully and critically analyze public comments submitted to the FDA on issues of tobacco regulation. Copyright © 2017 by Duke University Press.

  10. FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act.

    Science.gov (United States)

    Jenson, Desmond; Lester, Joelle; Berman, Micah L

    2016-05-01

    Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant product manipulation by the tobacco industry that had led to more addictive and attractive products. The law requires new tobacco products to undergo premarket review by the US Food and Drug Administration (FDA) before they can be sold. To assess FDA's implementation of its premarket review authorities, we reviewed FDA actions on new product applications, publicly available data on industry applications to market new products, and related FDA guidance documents and public statements. We conclude that FDA has not implemented the premarket review process in a manner that prioritises the protection of public health. In particular, FDA has (1) prioritised the review of premarket applications that allow for the introduction of new tobacco products over the review of potentially non-compliant products that are already on the market; (2) misallocated resources by accommodating the industry's repeated submissions of deficient premarket applications and (3) weakened the premarket review process by allowing the tobacco industry to market new and modified products that have not completed the required review process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. Isolation of Dermatophilus congolensis from a cat.

    Science.gov (United States)

    Kaya, O; Kirkan, S; Unal, B

    2000-03-01

    Dermatophilus congolensis was isolated from a cat with dermatitis. The isolate was sensitive to oxytetracyclin, streptomycin and penicillin but resistant to ampicillin, amoxicillin, gentamycin and cefoperazone.

  12. Controlled Archaeological Test Site (CATS) Facility

    Data.gov (United States)

    Federal Laboratory Consortium — CATS facility is at the Construction Engineering Research Laboratory (CERL), Champaign, IL. This 1-acre test site includes a variety of subsurface features carefully...

  13. Sublumbar abscess and diskospondylitis in a cat.

    Science.gov (United States)

    Packer, Rebecca A; Coates, Joan R; Cook, Cristi R; Lattimer, Jimmy C; O'Brien, Dennis P

    2005-01-01

    Diskospondylitis is uncommon in cats. We describe a cat with diskospondylitis of the L7-S1 intervertebral disk, and a concurrent sublumbar abscess. Radiographic, computed tomographic and ultrasonographic findings are presented. Aerobic and anaerobic cultures of blood and spinal fluid yielded no growth. Aerobic and anaerobic urine cultures resulted in growth of an Enterococcus sp. and Clostridium perfringens, respectively. The cat was successfully treated with enrofloxacin and amoxicillin/clavulanic acid. Clinical signs resolved completely, and based on follow-up ultrasonography there was no remaining evidence of the sublumbar abscess. Etiologic agents and outcome from other cats with diskospondylitis are reviewed.

  14. Polycystic kidney and liver disease in cats.

    Science.gov (United States)

    Bosje, J T; van den Ingh, T S; van der Linde-Sipman, J S

    1998-10-01

    This paper reviews 27 cases of polycystic disease of the kidneys and/or liver in cats. The multiple cysts in the kidneys were rounded in all but one case, as described in adult polycystic kidney disease in humans. In 68% of the cats presented with polycystic kidneys, there were also cystic changes of the liver (uni- or multilocular cysts and/or congenital hepatic fibrosis (CHF)). In 1 cat polycystic changes of kidneys and liver were accompanied by cysts in the pancreas. In 5 cases there was severe pancreas fibrosis. Twenty-one of the 27 cats were Persian or Persian-crossbred.

  15. ADVERTISING, THE FDA, AND THE TOBACCO SETTLEMENT: AS HOPES FOR SETTLEMENT DIM, CHALLENGES OF FDA AUTHORITY AND FIRST AMENDMENT CONCERNS ARE REKINDLED

    OpenAIRE

    Liu, Levi

    1998-01-01

    This discussion will attempt to explore the controversy and dynamics of FDA authority over tobacco advertising and the constitutionality of the existing (although unapproved) restrictions on tobacco advertising, the two major obstacles to the firm establishment of government limitations on the tobacco industry's commercial speech.

  16. EUROmediCAT signal detection

    DEFF Research Database (Denmark)

    Given, Joanne E; Loane, Maria; Luteijn, Johannes Michiel

    2016-01-01

    AIMS: To evaluate congenital anomaly (CA)-medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation. METHODS: Data from 15 EUROCAT registries (1995-2011) with medication exposures at the chemical substance (5th level...... persisted after data validation, a literature review was conducted for prior evidence of human teratogenicity. RESULTS: Thirteen out of 27 CA-medication exposure signals, based on 389 exposed cases, passed data validation. There was some prior evidence in the literature to support six signals (gastroschisis...

  17. Respiratory nematodes in cat populations of Italy.

    Science.gov (United States)

    Di Cesare, Angela; Veronesi, Fabrizia; Grillotti, Eleonora; Manzocchi, Simone; Perrucci, Stefania; Beraldo, Paola; Cazzin, Stefania; De Liberato, Claudio; Barros, Luciano A; Simonato, Giulia; Traversa, Donato

    2015-12-01

    The occurrence of common respiratory parasites of domestic cats (the metastrongyloid "cat lungworm" Aelurostrongylus abstrusus and the trichuroid Capillaria aerophila) and of neglected respiratory nematodes of felids (Troglostrongylus brevior, Angiostrongylus chabaudi and Oslerus rostratus) was here evaluated in two and three geographical sites of Northern and Central Italy, respectively. In 2014-2015, individual fecal samples of 868 domestic cats were examined microscopically and genetically, and epidemiological data related to parasitic infections were evaluated as possible risk factors by binary logistic regression models. The most common parasite was A. abstrusus in both mono- and poli-specific infections, followed by T. brevior and C. aerophila, while cats scored negative for other parasites. Cats positive for A. abstrusus (1.9-17 % infection rate) and C. aerophila (0.9-4.8 % infection rate) were found in all examined sites, while cats scored positive for T. brevior (1-14.3 % infection rate) in four sites. Also, T. brevior was here found for the first time in a domestic cat from a mountainous area of Northern Italy. The occurrence of lungworms was statistically related to the presence of respiratory signs and more significant in cats with mixed infection by other lungworms and/or intestinal parasites. Cats living in site C of Central Italy resulted statistically more at risk of infection for lungworms than cats living in the other study sites, while animals ageing less than 1 year were at more risk for troglostrongylosis. Finally, the presence of lungworms was more significant in cats with mixed infection by other lungworms and/or intestinal parasites. These results are discussed under epidemiological and clinical points of views.

  18. Overweight adult cats have significantly lower voluntary physical activity than adult lean cats.

    Science.gov (United States)

    de Godoy, Maria Rc; Shoveller, Anna K

    2017-12-01

    Objectives The objectives of the current pilot study were to evaluate whether body condition score (BCS) and body weight are significantly related to physical activity counts, and to evaluate potential interaction between BCS and voluntary physical activity measured over a 14 day period. Methods Ten (five lean, five overweight), neutered, adult American Shorthair cats were selected for this study (median age 4 ± 0.5 years). Cats with a BCS of ⩽3.0 were considered lean, whereas cats with a BCS >3.0 were considered overweight, using a 5-point scale. Cats were housed in a free-living environment with indoor/outdoor access and were individually fed once daily a commercially available dry extruded diet and allowed 1 h to eat. Voluntary physical activity was measured consecutively for 14 days using the Actical Activity Monitors that were worn parallel to the ribs and attached via a harness. Results Lean cats had a greater mean total daily voluntary physical activity ( P = 0.0059), and a greater voluntary physical activity during light ( P = 0.0023) and dark ( P = 0.0446) periods, with overweight cats having 60% of the physical activity of lean cats. Lean cats were more active before feeding and during animal care procedures. These data suggest that lean cats have a greater anticipatory physical activity prior to feeding and are more eager to have social interaction with humans than overweight cats. A significant interaction was observed between day of physical activity measurement and BCS for total daily voluntary physical activity ( P = 0.0133) and activity during the light period ( P = 0.0016) where lean cats were consistently more active than overweight cats. In general, cats were more active during weekdays vs weekends. Conclusions and relevance The results of this study suggest that overweight cats are less active than lean cats and that voluntary physical activity level appears to be influenced by social interaction with humans.

  19. Domestic cat allergen and allergic sensitisation in young children

    NARCIS (Netherlands)

    Chen, Chih-Mei; Gehring, Ulrike; Wickman, Magnus; Hoek, Gerard; Giovannangelo, Mariella; Nordling, Emma; Wijga, Alet; de Jongste, Johan; Pershagen, Goeran; Almqvist, Catarina; Kerkhof, Marjan; Bellander, Tom; Wichmann, H. -Erich; Brunekreef, Bert; Heinrich, Joachim

    Studies have presented conflicting associations between cat allergen exposure and sensitisation and atopic disease. We therefore investigated the association between the observed domestic cat allergen level and cat sensitisation in young children in four study populations from three European

  20. Cats

    Science.gov (United States)

    ... treatment in 4-6 weeks. More MRSA (Methicillin-Resistant Staphylococcus aureus ) Staphylococcus aureus is a common type of bacteria ... on the skin of people and animals. Methicillin-resistant Staphylococcus aureus (MRSA) is the same bacterium that has become ...

  1. Cats, Cancer and Comparative Oncology

    Directory of Open Access Journals (Sweden)

    Claire M. Cannon

    2015-06-01

    Full Text Available Naturally occurring tumors in dogs are well-established models for several human cancers. Domestic cats share many of the benefits of dogs as a model (spontaneous cancers developing in an immunocompetent animal sharing the same environment as humans, shorter lifespan allowing more rapid trial completion and data collection, lack of standard of care for many cancers allowing evaluation of therapies in treatment-naïve populations, but have not been utilized to the same degree in the One Medicine approach to cancer. There are both challenges and opportunities in feline compared to canine models. This review will discuss three specific tumor types where cats may offer insights into human cancers. Feline oral squamous cell carcinoma is common, shares both clinical and molecular features with human head and neck cancer and is an attractive model for evaluating new therapies. Feline mammary tumors are usually malignant and aggressive, with the ‘triple-negative’ phenotype being more common than in humans, offering an enriched population in which to examine potential targets and treatments. Finally, although there is not an exact corollary in humans, feline injection site sarcoma may be a model for inflammation-driven tumorigenesis, offering opportunities for studying variations in individual susceptibility as well as preventative and therapeutic strategies.

  2. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    Science.gov (United States)

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  3. Gas separation performance of 6FDA-based polyimides with different chemical structures

    KAUST Repository

    Qiu, Wulin

    2013-10-01

    This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.

  4. Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

    Science.gov (United States)

    Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

    2016-02-01

    Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Cool Cats: Feline Fun with Abstract Art.

    Science.gov (United States)

    Lambert, Phyllis Gilchrist

    2002-01-01

    Presents a lesson that teaches students about abstract art in a fun way. Explains that students draw cats, learn about the work of Pablo Picasso, and, in the style of Picasso, combine the parts of the cats (tail, legs, head, body) together in unconventional ways. (CMK)

  6. Getting a CAT Scan (For Kids)

    Medline Plus

    Full Text Available ... Teens Teens site Sitio para adolescentes Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol ... For Kids / Getting a CAT Scan (Video) Print en español Obtención de una tomografía computada (video) CAT ...

  7. Criptococose em felino Cryptococcosis in cat

    Directory of Open Access Journals (Sweden)

    F.J.F. Sant’Ana

    1999-08-01

    Full Text Available A case of cryptococcosis in a cat refferred to the Hospital Veterinário da Universidade Federal Rural de Pernambuco is described. The cat was euthanized and the microscopic examination of a firm mass observed in the nasal cavity was accomplished. Cryptococcus sp. and a chronic inflammatory process was observed throughout the tissue.

  8. Quantum Computer Games: Schrodinger Cat and Hounds

    Science.gov (United States)

    Gordon, Michal; Gordon, Goren

    2012-01-01

    The quantum computer game "Schrodinger cat and hounds" is the quantum extension of the well-known classical game fox and hounds. Its main objective is to teach the unique concepts of quantum mechanics in a fun way. "Schrodinger cat and hounds" demonstrates the effects of superposition, destructive and constructive interference, measurements and…

  9. Bacterial reproductive pathogens of cats and dogs.

    Science.gov (United States)

    Graham, Elizabeth M; Taylor, David J

    2012-05-01

    With the notable exception of Brucella canis, exogenous bacterial pathogens are uncommon causes of reproductive disease in cats and dogs. Most bacterial reproductive infections are endogenous, and predisposing factors for infection are important. This article reviews the etiology, pathogenesis, clinical presentation, diagnosis, treatment, and public health significance of bacterial reproductive pathogens in cats and dogs.

  10. Getting a CAT Scan (For Kids)

    Medline Plus

    Full Text Available ... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body Works ... Español Getting a CAT Scan (Video) KidsHealth / For Kids / Getting a CAT Scan (Video) Print en español ...

  11. FDA 2011 process validation guidance: lifecycle compliance model.

    Science.gov (United States)

    Campbell, Cliff

    2014-01-01

    This article has been written as a contribution to the industry's efforts in migrating from a document-driven to a data-driven compliance mindset. A combination of target product profile, control engineering, and general sum principle techniques is presented as the basis of a simple but scalable lifecycle compliance model in support of modernized process validation. Unit operations and significant variables occupy pole position within the model, documentation requirements being treated as a derivative or consequence of the modeling process. The quality system is repositioned as a subordinate of system quality, this being defined as the integral of related "system qualities". The article represents a structured interpretation of the U.S. Food and Drug Administration's 2011 Guidance for Industry on Process Validation and is based on the author's educational background and his manufacturing/consulting experience in the validation field. The U.S. Food and Drug Administration's Guidance for Industry on Process Validation (2011) provides a wide-ranging and rigorous outline of compliant drug manufacturing requirements relative to its 20(th) century predecessor (1987). Its declared focus is patient safety, and it identifies three inter-related (and obvious) stages of the compliance lifecycle. Firstly, processes must be designed, both from a technical and quality perspective. Secondly, processes must be qualified, providing evidence that the manufacturing facility is fully "roadworthy" and fit for its intended purpose. Thirdly, processes must be verified, meaning that commercial batches must be monitored to ensure that processes remain in a state of control throughout their lifetime.

  12. Cats in Czech Rural and Urban Households

    Directory of Open Access Journals (Sweden)

    E. Baranyiová

    2006-01-01

    Full Text Available The aim of this study was to elucidate the effects of rural and urban environments on the coexistence of humans and their cats. From the obtained questionnaire data we selected the rural cats (R, n = 54 and compared them with urban cats (U, n = 144. The R group cats lived predominantly in family houses, U cats in urban apartments. The pressures of physical and social factors in the small niches of urban apartments (dwellings in Czech urban high-density living settings, though comfortable, are smaller than in numerous European countries; they prevailed in our U group resulted in statistically significant differences in only 31 (51.7% out of 60 traits under study. Among them, 15 (68.2% out of 22 concerned the conduct of household members, and 16 (42.1% out of 38 concerned the behaviour of their cats. Thus the conduct of people in U households showed relatively higher proportion of changes than the behaviour of their cats. U onwers more frequently purchased their cats (R = 24.1%, U = 48.6%, chi-square = 10.648, df = 4, p < 0.05, they kept the cat pedigrees (R = 37.0%, U = 75.4%, chisquare = 24.661, df = 1, p < 0.001, paid more attention to their cats ((R = 93.0%, U = 100.0%, chi-square = 8.950, df = 1, p < 0.005, talked to them daily (R = 87.0%, U = 98.6%, chi-square = 12.024, df = 1, p < 0.001, allowed them to use furniture (R = 77.8%, U = 100.0%, chi-square = 33.839, df = 1, p < 0.001, sleep in beds of family members (R = 61.1%, U = 95.1%, chi-square = 37.149, df = 1, p < 0.001, and celebrated their birthdays (R = 25.9%, U = 100.0%, chi-square = 7.014, df = 2, p < 0.05. Their cats were more destructive than R cats, hunted less and were less aggressive when stroked. However, they showed a slightly larger scope of aggressive behaviours and were more frequently described as nervous and restless. The nature of the significant differences found in this study indicates that the co-existence of cats with people in the urbanized world is becoming more

  13. Assessment of Clicker Training for Shelter Cats

    Science.gov (United States)

    Kogan, Lori

    2017-01-01

    Simple Summary Living conditions in animal shelters can be stressful for cats. Clicker training might be able to alleviate this stress, by giving cats an opportunity to learn new behaviors and interact with humans. In this study, we assessed the initial ability of 100 shelter cats to perform four cued behaviors: touching a target, sitting, spinning, and giving a high-five. Each cat completed 15, five-min training sessions over a two-week span. At the end of the program, we assessed the cats’ ability to perform the same behaviors. On average, the cats performed better on all four behaviors after clicker training, suggesting that the cats could learn to perform specific behaviors on cue. Individual cats with a higher level of interest in food showed greater gains in learning for two of the behaviors (high-five and touching a target). Cats with a bolder temperament at post-assessment demonstrated greater gains in learning than those classified as shy. We suggest that clicker training can be used to enhance cats’ well-being while they are housed in shelters, and that the learned behaviors might make them more desirable to adopters. Abstract Clicker training has the potential to mitigate stress among shelter cats by providing environmental enrichment and human interaction. This study assessed the ability of cats housed in a shelter-like setting to learn new behaviors via clicker training in a limited amount of time. One hundred shelter cats were enrolled in the study. Their baseline ability to perform four specific behaviors touching a target, sitting, spinning, and giving a high-five was assessed, before exposing them to 15, five-min clicker training sessions, followed by a post-training assessment. Significant gains in performance scores were found for all four cued behaviors after training (p = 0.001). A cat’s age and sex did not have any effect on successful learning, but increased food motivation was correlated with greater gains in learning for two of the

  14. Feral Cats: Too Long a Threat to Hawaiian Wildlife

    Science.gov (United States)

    Hess, Steven C.; Banko, Paul C.

    2006-01-01

    BACKGROUND Domestic cats (Felis catus) were first brought to Hawai`i aboard sailing ships of European explorers and colonists. The job of these predators was to control mice and rats on the ships during the long voyages. As in other places, cats were taken in and adopted by the families of Hawai`i and soon became household pets known as popoki. But cats have always been very well equipped to live and hunt on their own. On tropical archipelagos like the Hawaiian Islands where no other predatory mammals of comparable size existed, abundant and naive prey were particularly easy game, and cats soon thrived in the wild. Although the details of when cats first came to live in the wild remain little known, adventurers, writers, and naturalists of the day recorded some important observations. Feral cats were observed in remote wilderness around K?ilauea volcano on Hawai`i Island as early as 1840 by explorer William Brackenridge. Mark Twain was so impressed by the great abundance of cats when he visited Honolulu in 1866 that he reported his observations in the Sacramento Union newspaper, which were later reprinted in his book Roughing It: I saw... tame cats, wild cats, singed cats, individual cats, groups of cats, platoons of cats, companies of cats, regiments of cats, armies of cats, multitudes of cats, millions of cats...

  15. A Survey of Public Opinion on Cat (Felis catus) Predation and the Future Direction of Cat Management in New Zealand

    Science.gov (United States)

    Walker, Jessica K.; Bruce, Stephanie J.; Dale, Arnja R.

    2017-01-01

    Simple Summary The need to balance the benefits of cat ownership with the prevention of wildlife predation in New Zealand evokes strong and opposing views. This paper evaluates public concern for wildlife predation by four categories of cats; owned cats, managed-stray cats, unmanaged-stray cats, and feral cats. In addition, public support for a National Cat Management Strategy and a range of management techniques are investigated. Although the participants expressed concern regarding wildlife predation by all four categories of cats, the highest levels of concern were predation by feral cats, followed by unmanaged stray cats, then managed stray cats, and finally owned cats. The large majority of participants were found to support the implementation of a National Cat Management Strategy. Management techniques for owned cats that obtained public support included; cat exclusion zones, limits on ownership numbers, microchipping, Council registration, and de-sexing. Trap-Neuter-Return (TNR) was the favoured management technique for managed stray cats, while TNR and lethal management techniques were equally favoured for unmanaged stray cats. Lethal control methods were favoured for feral cats. The findings presented in this paper will be useful to consider during the development of legislation relating to cat management and predation in New Zealand. Abstract Cat predation is a prominent issue in New Zealand that provokes strong and opposing views. We explored, via 1011 face-to-face questionnaires, public opinion on (a) support for a National Cat Management Strategy (78% support); (b) concern regarding predation of wildlife by owned and un-owned cats (managed stray, unmanaged stray, and feral cats); (c) the acceptability of management techniques for owned cats; and (d) the acceptability of population management techniques for un-owned cats. The highest concern was expressed regarding the predation of non-native and native wildlife by feral cats (60 and 86% repectively

  16. Polycystic kidney disease in a Chartreux cat.

    Science.gov (United States)

    Volta, Antonella; Manfredi, Sabrina; Gnudi, Giacomo; Gelati, Aldo; Bertoni, Giorgio

    2010-02-01

    Polycystic kidney disease (PKD) is one of the most common genetic diseases in cats. It has been widely described in Persians and Persian-related cats and sporadically in other breeds. The purpose of the present paper is to describe the first reported case of PKD in a 12-year-old female Chartreux cat. The cat was referred with polyuria and polydipsia and enlarged and irregular kidneys at palpation. Multiple renal cysts and a single liver cyst were identified by ultrasound and the inherited pattern was confirmed by genetic test (polymerase chain reaction/restriction fragment length polymorphism (PCR/RFLP) assay). Chartreux cats should be included in the screening programme of PKD, and PKD should be always considered as a possible cause of chronic renal failure in this breed. Copyright 2009 ESFM and AAFP. Published by Elsevier Ltd. All rights reserved.

  17. Feline Epitheliotropic Mastocytic Conjunctivitis in 15 Cats.

    Science.gov (United States)

    Beckwith-Cohen, B; Dubielzig, R R; Maggs, D J; Teixeira, L B C

    2017-01-01

    Mast cell infiltration occurs in malignant, inflammatory (eg, allergic, infectious), and idiopathic disease processes in humans and animals. Here, we describe the clinical and histological features of a unique proliferative conjunctivitis occurring in 15 cats. Ocular specimens were examined histologically, and polymerase chain reaction (PCR) for feline herpesvirus 1 (FHV-1) was performed on ocular tissues obtained from 10 cats. Cats had a median age of 8 years (range: 7 months-17.5 years). The known median duration of ocular lesions prior to biopsy was 4 months (range: 1 week-3 years). Ocular disease was unilateral in 12 cats, and 9 cats had coexisting corneal disease. Clinically and histologically, proliferative or nodular conjunctival lesions were noted in 13 cats. The nictitating membrane was affected in 10 cats. Histologically, lesions were characterized by mixed inflammatory infiltrates with an abundance of Giemsa-positive and toluidine blue-positive intraepithelial and subepithelial mast cells, marked edema, and papillary epithelial hyperplasia. Feline herpesvirus 1 was demonstrated by PCR in 1 of 10 cats tested. Follow-up information was available for 14 cats: 8 had no recurrence during a median follow-up period of 17.5 months (range: 4.5-30 months), 2 underwent orbital exenteration, 3 had recurrence that was medically managed, and 1 cat had diffuse conjunctivitis at the time of biopsy and recurrence was deemed irrelevant. Various ocular medications were administered before and after surgical biopsy. This condition was designated as feline epitheliotropic mastocytic conjunctivitis, with intraepithelial mast cells being an essential feature and papillary epithelial proliferation being characteristic but not diagnostic alone. The condition appears to be uncommon and benign. Although the cause is unknown, an allergic component is possible.

  18. Credible deterrence: FDA and the Park Doctrine in the 21st century.

    Science.gov (United States)

    O'Leary, Patrick

    2013-01-01

    One of FDA's most powerful enforcement tools is strict liability criminal prosecution of corporate officers under the Park Doctrine. Recent comments by high-ranking FDA officials about using this power more aggressively and recent cases apparently making good on this promise have spurred commentators to call for the doctrine's demise. Critics argue that strict liability for corporate officers violates fundamental notions of fairness and the appropriate relationship between guilt and liability in criminal law. As a response to these critics, this article argues that the Park Doctrine continues to serve a valuable purpose in deterring conduct that endangers the public health and that structural, political, and practical limitations on FDA's use of Park prosecutions have been, and will continue to be, effective protections against the abuses critics fear. This article proposes a model for understanding why and how FDA uses its prosecutorial powers and assesses a sample of recent high-profile prosecutions under this model to argue that the modern "escalation" of Park prosecutions is in fact a continuation of FDA's historical policy.

  19. Idiopathic cystitis in domestic cats--beyond the lower urinary tract.

    Science.gov (United States)

    Buffington, C A T

    2011-01-01

    Signs of lower urinary tract (LUT) disease in domestic cats can be acute or chronic, and can result from variable combinations of abnormalities within the lumen of the LUT, the parenchyma of the LUT itself, or other organ system(s) that then lead to LUT dysfunction. In the majority of cats with chronic signs of LUT dysfunction, no specific underlying cause can be confirmed after standard clinical evaluation of the LUT, so these cats typically are classified as having idiopathic cystitis. A syndrome in human beings commonly known as interstitial cystitis (IC) shares many features in common with these cats, permitting comparisons between the two species. A wide range of similarities in abnormalities has been identified between these syndromes outside as well as inside the LUT. A variety of potential familial and developmental risk factors also have been identified. These results have permitted generation of the hypothesis that some of these people have a disorder affecting the LUT rather than a disorder of the LUT. This perspective has suggested alternative diagnostic strategies and novel approaches to treatment, at least in cats. The purpose of this review is to summarize research investigations into the various abnormalities present in cats, to compare some of these findings with those identified in human beings, and to discuss how they might modify perceptions about the etiopathogenesis, diagnosis, and treatment of cats with this disease. Dedication: I dedicate this contribution to Professor Dennis J. Chew, whose collaboration, patience, and support made it all possible. Copyright © 2011 by the American College of Veterinary Internal Medicine.

  20. Interspecies Transmission of Feline Immunodeficiency Virus from the Domestic Cat to the Tsushima Cat (Felis bengalensis euptilura) in the Wild

    Science.gov (United States)

    Nishimura, Yoshiaki; Goto, Yuko; Yoneda, Kumiko; Endo, Yasuyuki; Mizuno, Takuya; Hamachi, Masaharu; Maruyama, Hiroyuki; Kinoshita, Hirotoshi; Koga, Susumu; Komori, Mitsuru; Fushuku, Seigo; Ushinohama, Kanji; Akuzawa, Masao; Watari, Toshihiro; Hasegawa, Atsuhiko; Tsujimoto, Hajime

    1999-01-01

    Feline immunodeficiency virus (FIV) was isolated from a wild-caught Tsushima cat (Felis bengalensis euptilura), an endangered Japanese nondomestic subspecies of leopard cat (F. bengalensis). Phylogenetic analysis of the env gene sequences indicated that the FIV from the Tsushima cat belonged to a cluster of subtype D FIVs from domestic cats. FIVs from both the Tsushima cat and the domestic cat showed similar levels of replication and cytopathicity in lymphoid cell lines derived from these two species. The results indicated the occurrence of interspecies transmission of FIV from the domestic cat to the Tsushima cat in the wild. PMID:10438892

  1. Corneal hemangiosarcoma in a cat.

    Science.gov (United States)

    Cazalot, G; Regnier, A; Deviers, A; Serra, F; Lucas, M N; Etienne, C L; Letron, I Raymond

    2011-09-01

    A 10 year-old castrated male Domestic Short-hair cat with a history of chronic bilateral keratitis was referred for assessment of a red, elevated mass involving the left cornea. The rapid growth of the mass, over a month period in combination with pronounced vascularization and invasion of the corneal surface suggested an aggressive inflammatory or neoplastic process. Following keratectomy, the lesion was diagnosed histopathologically as a hemangiosarcoma. The tumor recurred locally within 3 weeks and enucleation was performed. Histopathologic examination of the globe confirmed the diagnosis and did not reveal infiltration of the limbus and conjunctiva. No signs of local recurrence or metastatic disease have been observed 18 months following enucleation. To the authors' knowledge this is the first case of primary corneal hemangiosarcoma described in the feline species. © 2011 American College of Veterinary Ophthalmologists.

  2. Birds be safe: Can a novel cat collar reduce avian mortality by domestic cats (Felis catus?

    Directory of Open Access Journals (Sweden)

    S.K. Willson

    2015-01-01

    Full Text Available The domestic cat (Felis catus has been described as the largest anthropogenic threat to songbird populations in North America. We examined the effectiveness of a novel cat collar in reducing avian and small mammal mortality by cats. The 2-inch wide Birdsbesafe® collar cover (CC is worn over a nylon quick-release collar, and the bright colors and patterns of the CC are hypothesized to warn birds of approaching cats. We conducted two seasonal trials, each lasting 12 weeks, in autumn 2013 (n=54 cats and spring 2014 (n=19 cats. Cats were randomly assigned to two groups, and CCs with interior collars were removed or put on every two weeks, to control for weather fluctuations and seasonal change. Cats wearing Birdsbesafe® CCs killed 19 times fewer birds than uncollared cats in the spring trial, and 3.4 times fewer birds in the fall. Birdsbesafe® CCs were extremely effective at reducing predation on birds. Small mammal data were less clear, but did decrease predation by half in the fall. The Birdsbesafe® CC is a highly effective device for decreasing bird predation, especially in the spring season. We suggest that the CCs be used as a conservation tool for owned as well as feral cats.

  3. Environmental Aspects of Domestic Cat Care and Management: Implications for Cat Welfare

    Science.gov (United States)

    Stella, Judith L.

    2016-01-01

    Domestic cats (Felis silvestris catus) are the most commonly kept companion animals in the US with large populations of owned (86 million), free-roaming (70 million), research (13,000), and shelter (2-3 million) cats. Vast numbers of cats are maintained in homes and other facilities each year and are reliant on humans for all of their care. Understanding cat behavior and providing the highest quality environments possible, including positive human-cat interactions, based on research could help improve the outcomes of biomedical research, shelter adoptions, and veterinary care, as well as overall cat welfare. Often, however, cats' needs are inadequately met in homes and some aspects may also not be well met in research colonies and shelters, despite the fact that similar problems are likely to be encountered in all of these environments. This paper provides a brief overview of common welfare challenges associated with indoor housing of domestic cats. Essential considerations for cage confinement are reviewed, along with implications of poor cat coping, such as weakening of the human-animal bond and relinquishment to shelters. The important role that environmental management plays in cat behavior and welfare outcomes is explored along with the need for additional research in key areas. PMID:27774506

  4. FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.

    Science.gov (United States)

    Grant, Evita V

    Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

  5. The FDA's role in medical device clinical studies of human subjects

    Science.gov (United States)

    Saviola, James

    2005-03-01

    This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

  6. Cats and Carbohydrates: The Carnivore Fantasy?

    Science.gov (United States)

    Verbrugghe, Adronie; Hesta, Myriam

    2017-01-01

    The domestic cat’s wild ancestors are obligate carnivores that consume prey containing only minimal amounts of carbohydrates. Evolutionary events adapted the cat’s metabolism and physiology to this diet strictly composed of animal tissues and led to unique digestive and metabolic peculiarities of carbohydrate metabolism. The domestic cat still closely resembles its wild ancestor. Although the carnivore connection of domestic cats is well recognised, little is known about the precise nutrient profile to which the digestive physiology and metabolism of the cat have adapted throughout evolution. Moreover, studies show that domestic cats balance macronutrient intake by selecting low-carbohydrate foods. The fact that cats evolved consuming low-carbohydrate prey has led to speculations that high-carbohydrate diets could be detrimental for a cat’s health. More specifically, it has been suggested that excess carbohydrates could lead to feline obesity and diabetes mellitus. Additionally, the chances for remission of diabetes mellitus are higher in cats that consume a low-carbohydrate diet. This literature review will summarise current carbohydrate knowledge pertaining to digestion, absorption and metabolism of carbohydrates, food selection and macronutrient balancing in healthy, obese and diabetic cats, as well as the role of carbohydrates in prevention and treatment of obesity and diabetes mellitus. PMID:29140289

  7. Cats and Carbohydrates: The Carnivore Fantasy?

    Directory of Open Access Journals (Sweden)

    Adronie Verbrugghe

    2017-11-01

    Full Text Available The domestic cat’s wild ancestors are obligate carnivores that consume prey containing only minimal amounts of carbohydrates. Evolutionary events adapted the cat’s metabolism and physiology to this diet strictly composed of animal tissues and led to unique digestive and metabolic peculiarities of carbohydrate metabolism. The domestic cat still closely resembles its wild ancestor. Although the carnivore connection of domestic cats is well recognised, little is known about the precise nutrient profile to which the digestive physiology and metabolism of the cat have adapted throughout evolution. Moreover, studies show that domestic cats balance macronutrient intake by selecting low-carbohydrate foods. The fact that cats evolved consuming low-carbohydrate prey has led to speculations that high-carbohydrate diets could be detrimental for a cat’s health. More specifically, it has been suggested that excess carbohydrates could lead to feline obesity and diabetes mellitus. Additionally, the chances for remission of diabetes mellitus are higher in cats that consume a low-carbohydrate diet. This literature review will summarise current carbohydrate knowledge pertaining to digestion, absorption and metabolism of carbohydrates, food selection and macronutrient balancing in healthy, obese and diabetic cats, as well as the role of carbohydrates in prevention and treatment of obesity and diabetes mellitus.

  8. The CATS Service: An Astrophysical Research Tool

    Directory of Open Access Journals (Sweden)

    O V Verkhodanov

    2009-03-01

    Full Text Available We describe the current status of CATS (astrophysical CATalogs Support system, a publicly accessible tool maintained at Special Astrophysical Observatory of the Russian Academy of Sciences (SAO RAS (http://cats.sao.ru allowing one to search hundreds of catalogs of astronomical objects discovered all along the electromagnetic spectrum. Our emphasis is mainly on catalogs of radio continuum sources observed from 10 MHz to 245 GHz, and secondly on catalogs of objects such as radio and active stars, X-ray binaries, planetary nebulae, HII regions, supernova remnants, pulsars, nearby and radio galaxies, AGN and quasars. CATS also includes the catalogs from the largest extragalactic surveys with non-radio waves. In 2008 CATS comprised a total of about 109 records from over 400 catalogs in the radio, IR, optical and X-ray windows, including most source catalogs deriving from observations with the Russian radio telescope RATAN-600. CATS offers several search tools through different ways of access, e.g. via Web-interface and e-mail. Since its creation in 1997 CATS has managed about 105requests. Currently CATS is used by external users about 1500 times per day and since its opening to the public in 1997 has received about 4000 requests for its selection and matching tasks.

  9. Environmental enrichment choices of shelter cats.

    Science.gov (United States)

    Ellis, J J; Stryhn, H; Spears, J; Cockram, M S

    2017-08-01

    Choices made by cats between different types of environmental enrichment may help shelters to prioritize how to most effectively enrich cat housing, especially when limited by space or funds. This study investigates the environmental enrichment use of cats in a choice test. Twenty-six shelter cats were kept singularly in choice chambers for 10days. Each chamber had a central area and four centrally-linked compartments containing different types of environmental enrichment: 1) an empty control, 2) a prey-simulating toy, 3) a perching opportunity, and 4) a hiding opportunity. Cat movement between compartments was quantitatively recorded using a data-logger. Enriched compartments were visited significantly more frequently during the light period than during the dark period. Cats spent a significantly greater percentage of time in the hiding compartment (median=55%, IQR=46) than in the toy compartment (median=2%, IQR=9), or in the empty control compartment (median=4%, IQR=4). These results provide additional evidence to support the value of a hiding box to cats housed in a novel environment, in that they choose hiding relative to other types of environmental enrichment. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Toxoplasma gondii seroprevalence varies by cat breed.

    Directory of Open Access Journals (Sweden)

    Kärt Must

    Full Text Available Toxoplasma gondii is a widespread zoonotic parasite that is relevant for veterinary and public health. The domestic cat, the definitive host species with the largest worldwide population, has become evolutionarily and epidemiologically the most important host of T. gondii. The outcome of T. gondii infection is influenced by congenital and acquired host characteristics. We detected differences in T. gondii seroprevalence by cat breed in our previous studies. The aims of this study were to estimate T. gondii seroprevalence in selected domestic cat breeds, and to evaluate whether being of a certain breed is associated with T. gondii seropositivity, when the age and lifestyle of the cat are taken into account. The studied breeds were the Birman, British Shorthair, Burmese, Korat, Norwegian Forest Cat, Ocicat, Persian, and Siamese. Plasma samples were analyzed for the presence of immunoglobulin G antibodies against T. gondii with a commercial direct agglutination test at dilution 1:40. The samples were accompanied by owner-completed questionnaires that provided background data on the cats. Overall, 41.12% of the 1121 cats tested seropositive, and the seroprevalence increased with age. The Burmese had the lowest seroprevalence (18.82% and the Persian had the highest (60.00%. According to the final multivariable logistic regression model, the odds to test seropositive were four to seven times higher in Birmans, Ocicats, Norwegian Forest Cats, and Persians when compared with the Burmese, while older age and receiving raw meat were also risk factors for T. gondii seropositivity. This study showed that T. gondii seroprevalence varies by cat breed and identified being of certain breeds, older age, and receiving raw meat as risk factors for seropositivity.

  11. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    OpenAIRE

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigare...

  12. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

    2016-01-01

    Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

  13. Levelling the Playing Field: the FDA's Regulation of Nicotine Dependence Products

    OpenAIRE

    Szubin, Adam J.

    1999-01-01

    There is a great need for the increased development and use of nicotine dependence products (NDPs) in this country. A creative regulatory approach, such as the FDA brought to tobacco regulation, could do an enormous amount of good. In the field of NDPs, as in every area of drug regulation, a new regulatory approach will bring with it costs and benefits. As our knowledge advances, the FDA should not be slow to adopt the same aggressive yet flexible approach to NDPs that it has adopted towards ...

  14. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Science.gov (United States)

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In partnership with NIST and the FDA, NCL has laid a solid, scientific foundation for using the power of nanotechnology to increase the potency and target the delivery

  15. Nasopharyngeal turbinates in brachycephalic dogs and cats.

    Science.gov (United States)

    Ginn, Jennifer A; Kumar, M S A; McKiernan, Brendan C; Powers, Barbara E

    2008-01-01

    This retrospective study reports the presence and incidence of nasal turbinates in the nasopharynx (nasopharyngeal turbinates) in a population of brachycephalic dogs and cats exhibiting signs of upper respiratory disease. Medical records were reviewed for 53 brachycephalic dogs and 10 brachycephalic cats undergoing upper airway endoscopy. Nasopharyngeal turbinates were identified in 21% of brachycephalic animals, including 21% of dogs and 20% of cats. Pugs accounted for 32% of all dogs in the study population and 82% of dogs with nasopharyngeal turbinates. The presence of nasopharyngeal turbinates may play a role in upper airway obstruction in the brachycephalic airway syndrome.

  16. Cytogenetic investigation of cat-eye syndrome.

    Science.gov (United States)

    Walknowska, J; Peakman, D; Weleber, R G

    1977-10-01

    Using multiple chromosomal banding techniques, we studied a child with typical cat-eye syndrome and ocular retraction syndrome. Although the mother was was chromosomally normal, other maternal relatives showed features of the cat-eye syndrome, suggesting the basic abnormality is heritable. The abnormal chromosome in our case was most likely the product of reciprocal translocation where short arm plus centromeric chromatin from two separate acrocentric chromosomes fused together. The chromosomes involved were probably No. 22 and either Nos. 13 or 14. The basic underlying defect in cat-eye syndrome may be a heritable fragile site or some other predisposition leading to complex chromosomal interchange.

  17. Adverse food reactions in dogs and cats.

    Science.gov (United States)

    Gaschen, Frédéric P; Merchant, Sandra R

    2011-03-01

    Adverse food reactions (AFR) are a common problem that may cause cutaneous and/or gastrointestinal signs in dogs and cats. They comprise food intolerance, food intoxication, and food allergy. Response to a dietary elimination trial and recurrence of signs during dietary provocation remain the centerpiece of diagnosis and management of dogs and cats with AFR. Response to an elimination trial is frequently observed in dogs and cats with chronic idiopathic enteropathies. However, only a fraction of them relapse after a dietary challenge. These animals may have mild to enteritis and/or colitis and benefit from various additional properties of the elimination diet. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Pain and adverse behavior in declawed cats.

    Science.gov (United States)

    Martell-Moran, Nicole K; Solano, Mauricio; Townsend, Hugh Gg

    2017-05-01

    Objectives The aim of this study was to assess the impact of onychectomy (declawing) upon subsequent development of back pain and unwanted behavior in cohorts of treated and control cats housed in two different locations. Methods This was a retrospective cohort study. In total, there was 137 declawed and 137 non-declawed cats, of which 176 were owned cats (88 declawed, 88 non-declawed) and 98 were shelter cats (49 declawed and 49 non-declawed). All cats were physically examined for signs of pain and barbering. The previous 2 years of medical history were reviewed for documented unwanted behavior such as inappropriate elimination and biting with minimal provocation and aggression. All declawed cats were radiographed for distal limb abnormalities, including P3 (third phalanx) bone fragments. The associations of declaw surgery with the outcomes of interest were examined using χ 2 analysis, two sample t-tests and manual, backwards, stepwise logistic regression. Results Significant increases in the odds of back pain (odds ratio [OR] 2.9), periuria/perichezia (OR 7.2), biting (OR 4.5) and barbering (OR 3.06) occurred in declawed compared with control cats. Of the 137 declawed cats, 86 (63%) showed radiographic evidence of residual P3 fragments. The odds of back pain (OR 2.66), periuria/perichezia (OR 2.52) and aggression (OR 8.9) were significantly increased in declawed cats with retained P3 fragments compared with those declawed cats without. Optimal surgical technique, with removal of P3 in its entirety, was associated with fewer adverse outcomes and lower odds of these outcomes, but operated animals remained at increased odds of biting (OR 3.0) and undesirable habits of elimination (OR 4.0) compared with non-surgical controls. Conclusions and relevance Declawing cats increases the risk of unwanted behaviors and may increase risk for developing back pain. Evidence of inadequate surgical technique was common in the study population. Among declawed cats, retained P3

  19. Earliest "Domestic" Cats in China Identified as Leopard Cat (Prionailurus bengalensis).

    Science.gov (United States)

    Vigne, Jean-Denis; Evin, Allowen; Cucchi, Thomas; Dai, Lingling; Yu, Chong; Hu, Songmei; Soulages, Nicolas; Wang, Weilin; Sun, Zhouyong; Gao, Jiangtao; Dobney, Keith; Yuan, Jing

    2016-01-01

    The ancestor of all modern domestic cats is the wildcat, Felis silvestris lybica, with archaeological evidence indicating it was domesticated as early as 10,000 years ago in South-West Asia. A recent study, however, claims that cat domestication also occurred in China some 5,000 years ago and involved the same wildcat ancestor (F. silvestris). The application of geometric morphometric analyses to ancient small felid bones from China dating between 5,500 to 4,900 BP, instead reveal these and other remains to be that of the leopard cat (Prionailurus bengalensis). These data clearly indicate that the origins of a human-cat 'domestic' relationship in Neolithic China began independently from South-West Asia and involved a different wild felid species altogether. The leopard cat's 'domestic' status, however, appears to have been short-lived--its apparent subsequent replacement shown by the fact that today all domestic cats in China are genetically related to F. silvestris.

  20. 9 CFR 113.39 - Cat safety tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cat safety tests. 113.39 Section 113... Procedures § 113.39 Cat safety tests. The safety tests provided in this section shall be conducted when... recommended for use in cats. (a) The cat safety test provided in this paragraph shall be used when the Master...

  1. Domestic Cat (Felis silvestris catus) Urine Odour as a Potential ...

    African Journals Online (AJOL)

    The aim of this study was to investigate the effects of cat urine odour extract on rodent pest species to reduce crop losses. Cat urine from the captured cats was drawn using cat catcher. Urinary catheter was inserted into the urethra up to the urinary bladder and a syringe attached to the urinary catheter was used to draw ...

  2. Salinomycin-induced polyneuropathy in cats: Morphologic and epidemiologic data

    NARCIS (Netherlands)

    Linde-Sipman, J.S. van der; Inch, T.S.G.A.M. van den; Nes, J.J. van; Verhagen, H.; Kersten, J.G.T.M.; Beynen, A.C.; Plekkringa, R.

    1999-01-01

    In April 1996, an outbreak of toxic polyneuropathy in cats occurred in the Netherlands. All cats had been fed one of two brands of dry cat food from one manufacturer. Chemical analyses of these foods, stomach contents, and liver and kidney of affected cats revealed contamination with the ionophor

  3. Environmental Aspects of Domestic Cat Care and Management: Implications for Cat Welfare

    Directory of Open Access Journals (Sweden)

    Judith L. Stella

    2016-01-01

    Full Text Available Domestic cats (Felis silvestris catus are the most commonly kept companion animals in the US with large populations of owned (86 million, free-roaming (70 million, research (13,000, and shelter (2-3 million cats. Vast numbers of cats are maintained in homes and other facilities each year and are reliant on humans for all of their care. Understanding cat behavior and providing the highest quality environments possible, including positive human-cat interactions, based on research could help improve the outcomes of biomedical research, shelter adoptions, and veterinary care, as well as overall cat welfare. Often, however, cats’ needs are inadequately met in homes and some aspects may also not be well met in research colonies and shelters, despite the fact that similar problems are likely to be encountered in all of these environments. This paper provides a brief overview of common welfare challenges associated with indoor housing of domestic cats. Essential considerations for cage confinement are reviewed, along with implications of poor cat coping, such as weakening of the human-animal bond and relinquishment to shelters. The important role that environmental management plays in cat behavior and welfare outcomes is explored along with the need for additional research in key areas.

  4. Channel CAT: A Tactical Link Analysis Tool

    National Research Council Canada - National Science Library

    Coleman, Michael

    1997-01-01

    .... This thesis produced an analysis tool, the Channel Capacity Analysis Tool (Channel CAT), designed to provide an automated tool for the analysis of design decisions in developing client-server software...

  5. Getting a CAT Scan (For Kids)

    Medline Plus

    Full Text Available ... Health Food & Fitness Diseases & Conditions Infections Drugs & Alcohol School & Jobs Sports Expert Answers (Q&A) Staying Safe Videos for Educators Search English Español Getting a CAT Scan (Video) KidsHealth / For ...

  6. [Polycystic kidney disease in a Persian cat].

    Science.gov (United States)

    Hege, R; Zimmer, C; Reusch, C

    2001-04-01

    This case report is about a 9-year-old male castrated Persian cat with chronic renal failure. After physical examination and ultrasonography polycystic kidney disease (PKD) was diagnosed. Various aspects of etiology, pathophysiology and diagnosis of PKD are discussed.

  7. A cross-species alignment tool (CAT)

    DEFF Research Database (Denmark)

    Li, Heng; Guan, Liang; Liu, Tao

    2007-01-01

    sensitive methods which are usually applied in aligning inter-species sequences. RESULTS: Here we present a new algorithm called CAT (for Cross-species Alignment Tool). It is designed to align mRNA sequences to mammalian-sized genomes. CAT is implemented using C scripts and is freely available on the web......BACKGROUND: The main two sorts of automatic gene annotation frameworks are ab initio and alignment-based, the latter splitting into two sub-groups. The first group is used for intra-species alignments, among which are successful ones with high specificity and speed. The other group contains more...... at http://xat.sourceforge.net/. CONCLUSIONS: Examined from different angles, CAT outperforms other extant alignment tools. Tested against all available mouse-human and zebrafish-human orthologs, we demonstrate that CAT combines the specificity and speed of the best intra-species algorithms, like BLAT...

  8. Effects of experimental amitraz intoxication in cats

    Directory of Open Access Journals (Sweden)

    S.F. Andrade

    2007-10-01

    Full Text Available This work studied the effects of experimental amitraz intoxication in cats. Sixteen cats were randomly divided equally into two groups: amitraz group - animals received 1.5% amitraz at 1mg/kg IV; and the control group - animals without amitraz. Physiological parameters from blood, cardiorespiratory system, and sedation indicators were quantified over time up to 360 minutes. Blood profile, urea, creatinine, alananine aminotransferase and aspartate aminotransferase were not affected by amitraz. Sedation, loss of reflexes, hypothermia, bradycardia, bradyarrhythmia, hypotension, bradypnea, mydriasis, besides transitory hyperglycemia, hypoinsulinemia and decrease of cortisol levels were observed in cats experimentally exposed to amitraz. The alpha2-adrenergic effects induced by amitraz intoxication in cats are very similar to the same effects reported in others species, contributing with more information about this type of intoxication to veterinary toxicology.

  9. SWMM-CAT User’s Guide

    Science.gov (United States)

    The Storm Water Management Model Climate Adjustment Tool (SWMM-CAT) is a simple to use software utility that allows future climate change projections to be incorporated into the Storm Water Management Model (SWMM).

  10. Second order Horner's syndrome in a cat.

    Science.gov (United States)

    De Risio, Luisa; Fraser McConnell, James

    2009-08-01

    This case report describes the clinical and magnetic resonance imaging (MRI) findings of a 3.5-year-old, male neutered, domestic shorthair cat with second order Horner's syndrome as the only clinical abnormality. The neuroanatomical pathway of the sympathetic innervation to the eye, differential diagnoses for Horner's syndrome in cats, and the interpretation of pharmacological testing are reviewed. The unusual MRI findings and the value of fat-suppressed MRI sequences are discussed.

  11. Neutropenia in cats with the Chediak-Higashi syndrome.

    OpenAIRE

    Prieur, D J; Collier, L L

    1987-01-01

    Thirteen cats with Chediak-Higashi syndrome and 22 control cats from the same colony, were evaluated for neutropenia. The absolute neutrophil counts of the Chediak-Higashi syndrome cats were significantly less (P less than 0.05) than those of the control cats. It is concluded that Chediak-Higashi syndrome cats, like Chediak-Higashi syndrome humans, have a neutropenia associated with the other manifestations of the syndrome. Lysozyme activity which was undetectable in the serum of both Chediak...

  12. Major Parasitic Zoonoses Associated with Dogs and Cats in Europe.

    Science.gov (United States)

    Baneth, G; Thamsborg, S M; Otranto, D; Guillot, J; Blaga, R; Deplazes, P; Solano-Gallego, L

    2016-07-01

    Some of the most important zoonotic infectious diseases are associated with parasites transmitted from companion animals to man. This review describes the main parasitic zoonoses in Europe related to dogs and cats, with particular emphasis on their current epidemiology. Toxoplasmosis, leishmaniosis, giardiosis, echinococcosis, dirofilariosis and toxocariosis are described from the animal, as well as from the human host perspectives, with an emphasis on parasite life cycle, transmission, pathogenicity, prevention and identification of knowledge gaps. In addition, priorities for research and intervention in order to decrease the risks and burden of these diseases are presented. Preventing zoonotic parasitic infections requires an integrated multidisciplinary 'One Health' approach involving collaboration between veterinary and medical scientists, policy makers and public health officials. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    Science.gov (United States)

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. The rosiglitazone decision process at FDA and EMA : What should we learn?

    NARCIS (Netherlands)

    Pouwels, Koen B.; van Grootheest, Kees

    2012-01-01

    In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased

  15. 21 CFR 14.15 - Committees working under a contract with FDA.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... contract is an advisory committee subject to the Federal Advisory Committee Act and this subpart depends...

  16. 21 CFR 111.610 - What records must be made available to FDA?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

  17. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  18. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an appeal? 1.405 Section 1.405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...

  19. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

  20. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs.

    Science.gov (United States)

    Kesselheim, Aaron S; Tan, Yongtian Tina; Darrow, Jonathan J; Avorn, Jerry

    2014-10-01

    Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve and influence the post-approval prescribing of specialty drugs. When specialty drugs show promise in early clinical trials, the FDA can expedite the drugs' availability to patients through expanded access programs and expedited approval pathways that speed regulatory authorization. After approval, to ensure that specialty drugs are directed to the patients who are most likely to benefit from them, the FDA can limit the scope of the drugs' indications, encourage the development of companion diagnostic tests to indicate which patients should receive the drugs, or require that manufacturers subject them to Risk Evaluation and Mitigation Strategies to ensure that their use is appropriately limited to a restricted population that is aware of the drugs' risks and benefits. Implementing these existing regulatory approaches can promote timely patient access to specialty drugs while preventing expensive and potentially inappropriate overuse. Project HOPE—The People-to-People Health Foundation, Inc.

  1. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements.... Examples of § 201.66 Standard Labeling and Modified Labeling Formats A. Section 201.66 Standard Labeling...

  2. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... Investigators.'' This draft guidance is intended to assist clinical investigators, industry, and FDA staff in... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...-7100). Send one self-addressed adhesive label to assist the office in processing your requests. Submit...

  3. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR

    Science.gov (United States)

    The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

  4. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging

    Science.gov (United States)

    The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

  5. A Good Year: FDA Approved Nine New Cancer Drugs in 2014

    Science.gov (United States)

    In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

  6. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    Science.gov (United States)

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

  7. Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

    Directory of Open Access Journals (Sweden)

    Juan Carlos Martínez-Aguayo

    2016-06-01

    Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

  8. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    Science.gov (United States)

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

  9. Constitutive expression of catABC genes in the aniline-assimilating bacterium Rhodococcus species AN-22: production, purification, characterization and gene analysis of CatA, CatB and CatC

    Science.gov (United States)

    Matsumura, Eitaro; Sakai, Masashi; Hayashi, Katsuaki; Murakami, Shuichiro; Takenaka, Shinji; Aoki, Kenji

    2005-01-01

    The aniline-assimilating bacterium Rhodococcus sp. AN-22 was found to constitutively synthesize CatB (cis,cis-muconate cycloisomerase) and CatC (muconolactone isomerase) in its cells growing on non-aromatic substrates, in addition to the previously reported CatA (catechol 1,2-dioxygenase). The bacterium maintained the specific activity of the three enzymes at an almost equal level during cultivation on succinate. CatB and CatC were purified to homogeneity and characterized. CatB was a monomer with a molecular mass of 44 kDa. The enzyme was activated by Mn2+, Co2+ and Mg2+. Native CatC was a homo-octamer with a molecular mass of 100 kDa. The enzyme was stable between pH 7.0 and 10.5 and was resistant to heating up to 90 °C. Genes coding for CatA, CatB and CatC were cloned and named catA, catB and catC respectively. The catABC genes were transcribed as one operon. The deduced amino acid sequences of CatA, CatB and CatC showed high identities with those from other Gram-positive micro-organisms. A regulator gene such as catR encoding a regulatory protein was not observed around the cat gene cluster of Rhodococcus sp. AN-22, but a possible relic of catR was found in the upstream region of catA. Reverse transcriptase-PCR and primer extension analyses showed that the transcriptional start site of the cat gene cluster was located 891 bp upstream of the catA initiation codon in the AN-22 strain growing on both aniline and succinate. Based on these data, we concluded that the bacterium constitutively transcribed the catABC genes and translated its mRNA into CatA, CatB and CatC. PMID:16156722

  10. Fatal toxoplasmosis in sand cats (Felis margarita).

    Science.gov (United States)

    Pas, An; Dubey, J P

    2008-09-01

    The sand cat (Felis margarita) is a small-sized felid occurring in the United Arab Emirates (UAE). The sand cat captive-breeding program at the Breeding Centre for Endangered Arabian Wildlife in Sharjah, UAE, has until recently been severely compromised by very high newborn mortality rates. Two different pairs of sand cats gave birth, respectively, to one and two litters (with a total of eight kittens) between 1999 and 2006. Seven out of eight kittens died between the third and 21st wk of life. Toxoplasmosis was confirmed as the cause of death in these two litters. Adult cats had high antibody titers to Toxoplasma gondii before pregnancy, suggesting that maternal immunity did not protect the kittens against infection with T. gondii and that maternal immunity might not have prevented transplacental transmission of the parasite. This observation contrasts with what is seen in domestic cats. To date, this is the first report on confirmed fatal toxoplasmosis and prevalence of T. gondii in sand cats.

  11. [Splenic abscess and cat-scratch disease].

    Science.gov (United States)

    Valdesoiro Navarrete, L; Pineda Solas, V; Martín Martín, C; Sanfeliu Sala, I; Cabezas Maspoch, R M; Sánchez Oespina, M

    2001-10-01

    Cat-scratch disease is caused by a Gram-negative bacillus known as Bartonella henselae. This disease is usually benign and causes regional adenitis that does not require treatment. However, some patients develop more serious atypical forms of the disease including prolonged systemic illness with hepatic and splenic abscesses.A 14-year-old girl was admitted to hospital with a 12-day history of persistent high fever and abdominal pain. Ultrasonography and computerized tomography of the abdomen revealed splenic abscesses. These findings, together with an antecedent of cat exposure, led to the suspicion of cat-scratch disease, which was confirmed by serology. The girl was treated with intramuscular ceftriaxone and clinical evolution was favorable. Splenic cat-scratch disease is infrequent. Cat-scratch disease sometimes presents as fever of unknown origin and consequently this disease should be considered in the differential diagnosis of prolonged fever. Although evolution is usually favorable, antibiotic therapy is recommended in systemic manifestations of cat-scratch disease.

  12. Effect of single-cat versus multi-cat home history on perceived behavioral stress in domestic cats (Felis silvestrus catus) in an animal shelter.

    Science.gov (United States)

    Broadley, Heidi M; McCobb, Emily C; Slater, Margaret R

    2014-02-01

    This study investigates the effect of living with other cats in a prior home on stress levels of cats recently surrendered to an animal shelter. A total of 63 cats was evaluated using a Cat-Stress-Score and an approach test. Cats were categorized in terms of previous home history with or without other cats. No significant difference was found in stress scores between cats from single-cat households and those from multiple-cat households, although single cats that had been in the shelter less than 4 days demonstrated higher stress levels. No significant difference was found between the two groups in terms of approach results. Results of this study suggest that, in traditional individual cage settings, cats that are not accustomed to living with other cats may experience more stress in the initial few days of attempting to adjust to shelter existence. Through the use of such assessments, shelter personnel may develop an increased awareness to the needs of these cats and attempt to provide measures to improve their well-being within the shelter environment.

  13. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  14. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    International Nuclear Information System (INIS)

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  15. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

    Directory of Open Access Journals (Sweden)

    Amy Corneli, PhD, MPH

    2017-06-01

    Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

  16. Martín Lutero en la historiografía católica y en la Iglesia católica actual

    Directory of Open Access Journals (Sweden)

    Antonio Rehbein Pesce

    2001-01-01

    Full Text Available Este artículo es una puesta al día referente a la imagen de Martín Lutero que proyectan teólogos e historiadores católicos en el siglo XX y las líneas matrices que sigue su investigación. Además, en una segunda parte, se enfoca a Lutero desde la Iglesia católica actual, donde se destaca, como un hito importante, la celebración del año 1983, quinto centenario de su nacimiento.This article is an update of the image of Martin Luther projected by 20th Catholic historians, and the lines of research being followed. In a second part, Luther is looked at from the actual Catholic church perspective, highlighting the 5th centenary of his birth, in 1983, as an important event.

  17. Functional Analyses of Bitter Taste Receptors in Domestic Cats (Felis catus.

    Directory of Open Access Journals (Sweden)

    Weiwei Lei

    Full Text Available Cats are obligate carnivores and under most circumstances eat only animal products. Owing to the pseudogenization of one of two subunits of the sweet receptor gene, they are indifferent to sweeteners, presumably having no need to detect plant-based sugars in their diet. Following this reasoning and a recent report of a positive correlation between the proportion of dietary plants and the number of Tas2r (bitter receptor genes in vertebrate species, we tested the hypothesis that if bitter perception exists primarily to protect animals from poisonous plant compounds, the genome of the domestic cat (Felis catus should have lost functional bitter receptors and they should also have reduced bitter receptor function. To test functionality of cat bitter receptors, we expressed cat Tas2R receptors in cell-based assays. We found that they have at least 7 functional receptors with distinct receptive ranges, showing many similarities, along with some differences, with human bitter receptors. To provide a comparative perspective, we compared the cat repertoire of intact receptors with those of a restricted number of members of the order Carnivora, with a range of dietary habits as reported in the literature. The numbers of functional bitter receptors in the terrestrial Carnivora we examined, including omnivorous and herbivorous species, were roughly comparable to that of cats thereby providing no strong support for the hypothesis that a strict meat diet influences bitter receptor number or function. Maintenance of bitter receptor function in terrestrial obligate carnivores may be due to the presence of bitter compounds in vertebrate and invertebrate prey, to the necessary role these receptors play in non-oral perception, or to other unknown factors. We also found that the two aquatic Carnivora species examined had fewer intact bitter receptors. Further comparative studies of factors driving numbers and functions of bitter taste receptors will aid in

  18. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications.

    Science.gov (United States)

    Böhm, Ruwen; von Hehn, Leocadie; Herdegen, Thomas; Klein, Hans-Joachim; Bruhn, Oliver; Petri, Holger; Höcker, Jan

    2016-01-01

    Pharmacovigilance contributes to health care. However, direct access to the underlying data for academic institutions and individual physicians or pharmacists is intricate, and easily employable analysis modes for everyday clinical situations are missing. This underlines the need for a tool to bring pharmacovigilance to the clinics. To address these issues, we have developed OpenVigil FDA, a novel web-based pharmacovigilance analysis tool which uses the openFDA online interface of the Food and Drug Administration (FDA) to access U.S. American and international pharmacovigilance data from the Adverse Event Reporting System (AERS). OpenVigil FDA provides disproportionality analyses to (i) identify the drug most likely evoking a new adverse event, (ii) compare two drugs concerning their safety profile, (iii) check arbitrary combinations of two drugs for unknown drug-drug interactions and (iv) enhance the relevance of results by identifying confounding factors and eliminating them using background correction. We present examples for these applications and discuss the promises and limits of pharmacovigilance, openFDA and OpenVigil FDA. OpenVigil FDA is the first public available tool to apply pharmacovigilance findings directly to real-life clinical problems. OpenVigil FDA does not require special licenses or statistical programs.

  19. De besluitvorming over werkzaamheid en veiligheid van rosiglitazon bij de FDA en de EMA. Wat zijn de lessen?

    NARCIS (Netherlands)

    Pouwels, Koen; Van Grootheest, Kees

    2013-01-01

    The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of

  20. Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

    NARCIS (Netherlands)

    Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.

    2014-01-01

    BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval

  1. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Science.gov (United States)

    2011-07-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use...

  2. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Science.gov (United States)

    2011-10-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  3. Use of field-portable XRF analyzers for rapid screening of toxic elements in FDA-regulated products.

    Science.gov (United States)

    Palmer, Peter T; Jacobs, Richard; Baker, Peter E; Ferguson, Kelly; Webber, Siri

    2009-04-08

    Analytical instrumentation continues its amazing evolution, especially in regard to generating ever more sensitive, faster, and reliable measurements. Perhaps the most difficult challenges are making these instruments small enough to use in the field, equipping them with well-designed software that facilitates and simplifies their use by nonexperts while preserving enough of their analytical capabilities to render them useful for a wide variety of applications. Perhaps the most impressive and underappreciated example of instruments that meet these criteria are field-portable X-ray fluorescence (XRF) analyzers. In the past, these analyzers have been routinely used for environmental applications (lead in paint and soil, metal particulates in air samples collected onto filters), geology studies (ore and soil analysis, precious metal identification), and recycling industries (alloy identification). However, their use in the analysis of toxic elements in food, food ingredients, dietary supplements, and medicinal and herbal products, especially within the FDA and regulatory environments, has been surprisingly limited to date. Although XRF will not replace atomic spectrometry techniques such as ICP-MS for sub-parts per million level analyses, it offers a number of significant advantages including minimal sample preparation, high sample throughputs, rapid and definitive identification of many toxic elements, and accurate quantitative results. As should be obvious from many recent news reports on elevated levels of toxic elements in children's lunchboxes, toys, and supplements, field-portable XRF analyzers can fill a very important niche and are becoming increasingly popular for a wide variety of elemental analysis applications. This perspective begins with a brief review of the theory of XRF to highlight the underlying principle, instrumentation, and spectra. It includes a discussion of various analytical figures of merit of XRF to illustrate its strengths and limitations

  4. Patient perspective: choosing or developing instruments.

    Science.gov (United States)

    Kirwan, John R; Fries, James F; Hewlett, Sarah; Osborne, Richard H

    2011-08-01

    Previous Outcome Measures in Rheumatology (OMERACT) meetings recognized that patients view outcomes of intervention from a different perspective. This preconference position paper briefly sets out 2 patient-reported outcome (PRO) instrument approaches, the PROMISE computer adaptive testing (CAT) system and development of a rheumatoid arthritis-specific questionnaire to measure fatigue; a tentative proposal for a PRO instrument development pathway is also made.

  5. Cat sensitization according to cat window of exposure in adult asthmatics

    NARCIS (Netherlands)

    Oryszczyn, M.-P.; van Ree, R.; Maccario, J.; Nadif, R.; Kauffmann, F.

    2009-01-01

    P>Background In adults, there is limited information on tolerance to cat, which may be reflected by high IgG(4) without IgE sensitization. Early exposure to cat may play a critical role. Objective The aim was to assess among adults the association of Fel d 1 IgG(4), Fel d 1 IgE, skin prick test

  6. Hypothermia in Uremic Dogs and Cats.

    Science.gov (United States)

    Kabatchnick, E; Langston, C; Olson, B; Lamb, K E

    2016-09-01

    The prevalence of uremic hypothermia (UH) and the effects of improving uremia on body temperature have not been determined in veterinary patients. To determine the prevalence of UH and correlations between uremia and body temperature in patients undergoing intermittent hemodialysis (IHD). Uremic dogs (n = 122) and cats (n = 79) treated by IHD at the Bobst Hospital of the Animal Medical Center from 1997 to 2013. Retrospective review of medical records. The prevalence of hypothermia was 38% in azotemic cats and 20.5% in azotemic dogs. Statistically significant temperature differences were observed between uremic and nonuremic dogs (nonuremic: mean, 100.8°F; range, 91.2-109.5°F; uremic: mean, 99.9°F; range, 95.6-103.8°F; P cats (nonuremic: mean, 100.6°F; range, 94.0-103.8°F; uremic: mean, 99.3°F; range, 92.3-103.4°F; P dog dialysis patients, significant models included (1) timing (pre-dialysis versus post-dialysis) with weight class (small [P dogs), (2) timing with serum creatinine concentration (P = .021), and (3) timing with BUN concentration (P cat dialysis patients, there was a significant interaction between timing and weight as a categorical variable (cats and dogs. Uremic patients are hypothermic compared to ill nonuremic patients and body temperatures increase when uremia is corrected with IHD in dogs and in cats >5 kg. In cats, UH seems to be a more prevalent phenomenon driven by uremia. Uremic hypothermia does occur in dogs, but body weight is a more important predictor of body temperature. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  7. Itraconazole for the treatment of cryptococcosis in cats.

    Science.gov (United States)

    Medleau, L; Jacobs, G J; Marks, M A

    1995-01-01

    Itraconazole was used in 35 cats with cryptococcosis. Treatment response was determined by comparing clinical signs before, during, and after treatment. It could not be evaluated in 7 cats because they died during treatment from causes unrelated to cryptococcosis. Of the remaining 28 cats, treatment response was classified as success in 16 cats (57%), as improvement in 8 cats (29%), and as a failure in 4 (14%). The failures were due to death or euthanasia from drug toxicity (1 cat), progressive fungal disease (2 cats), and relapse 1 year after treatment (1 cat). The cats that improved did not undergo a 1-year posttreatment evaluation because they were lost to follow-up (3 cats), died or were euthanatized for other reasons (4 cats), or had a noncompliant owner (1 cat). For the 16 cats in which treatment was successful, the median itraconazole dose was 13.8 mg/kg body weight daily (range, 10.9 to 26.7 mg/kg/d), and the median duration of treatment was 8.5 months (range, 4 to 16 months). Five of these cats had previously been treated unsuccessfully with ketoconazole.

  8. Neutropenia in cats with the Chediak-Higashi syndrome.

    Science.gov (United States)

    Prieur, D J; Collier, L L

    1987-01-01

    Thirteen cats with Chediak-Higashi syndrome and 22 control cats from the same colony, were evaluated for neutropenia. The absolute neutrophil counts of the Chediak-Higashi syndrome cats were significantly less (P less than 0.05) than those of the control cats. It is concluded that Chediak-Higashi syndrome cats, like Chediak-Higashi syndrome humans, have a neutropenia associated with the other manifestations of the syndrome. Lysozyme activity which was undetectable in the serum of both Chediak-Higashi syndrome and control cats was not of use for determining if the neutropenia was the result of neutrophil destruction. PMID:3651899

  9. A Survey of Public Opinion on Cat (Felis catus) Predation and the Future Direction of Cat Management in New Zealand.

    Science.gov (United States)

    Walker, Jessica K; Bruce, Stephanie J; Dale, Arnja R

    2017-07-03

    Cat predation is a prominent issue in New Zealand that provokes strong and opposing views. We explored, via 1011 face-to-face questionnaires, public opinion on (a) support for a National Cat Management Strategy (78% support); (b) concern regarding predation of wildlife by owned and un-owned cats (managed stray, unmanaged stray, and feral cats); (c) the acceptability of management techniques for owned cats; and (d) the acceptability of population management techniques for un-owned cats. The highest concern was expressed regarding the predation of non-native and native wildlife by feral cats (60 and 86% repectively), followed by unmanaged stray cats (59 and 86% respectively), managed stray cats (54 and 82% respectively), and finally owned cats (38 and 69% repectively). Limits to the number of cats owned and cat restriction zones received high levels of support (>65%), and compulsory microchipping, Council registration, and de-sexing were supported by the majority (>58%). Public support of population control methods for unowned cats was explored, and the influence of participant demographic variables on responses is described. These findings provide insight into public opinion regarding the management of cats in New Zealand, which should be considered during the development of legislation in this area.

  10. A Survey of Public Opinion on Cat (Felis catus Predation and the Future Direction of Cat Management in New Zealand

    Directory of Open Access Journals (Sweden)

    Jessica K. Walker

    2017-07-01

    Full Text Available Cat predation is a prominent issue in New Zealand that provokes strong and opposing views. We explored, via 1011 face-to-face questionnaires, public opinion on (a support for a National Cat Management Strategy (78% support; (b concern regarding predation of wildlife by owned and un-owned cats (managed stray, unmanaged stray, and feral cats; (c the acceptability of management techniques for owned cats; and (d the acceptability of population management techniques for un-owned cats. The highest concern was expressed regarding the predation of non-native and native wildlife by feral cats (60 and 86% repectively, followed by unmanaged stray cats (59 and 86% respectively, managed stray cats (54 and 82% respectively, and finally owned cats (38 and 69% repectively. Limits to the number of cats owned and cat restriction zones received high levels of support (>65%, and compulsory microchipping, Council registration, and de-sexing were supported by the majority (>58%. Public support of population control methods for unowned cats was explored, and the influence of participant demographic variables on responses is described. These findings provide insight into public opinion regarding the management of cats in New Zealand, which should be considered during the development of legislation in this area.

  11. Born to roam? Surveying cat owners in Tasmania, Australia, to identify the drivers and barriers to cat containment.

    Science.gov (United States)

    McLeod, Lynette J; Hine, Donald W; Bengsen, Andrew J

    2015-12-01

    Free-roaming domestic cats, Felis catus, are a major public nuisance in neighbourhoods across the world, and have been linked to biodiversity loss and a host of community health problems. Owners who let their cats roam, also place their cats at risk of serious injury. One management strategy that is gaining considerable support involves encouraging cat owners to contain their pets within their property. Contemporary behaviour change models highlight the importance of identifying drivers and barriers that encourage and discourage target behaviours such as cat containment. Results from a random dial phone survey of 356 cat owners in northern Tasmania identified four distinct cat containment profiles: owners who contained their cat all the time, owners who only contained their cat at night, owners who sporadically contained their cat with no set routine, and owners who made no attempt to contain their pet. Our results indicated that cat-owners' decisions to contain or not contain their cats were guided by a range of factors including owners' beliefs about their ability to implement an effective containment strategy and their views about the physical and psychological needs of their cats. The results are discussed in terms of improving the behavioural effectiveness of cat containment interventions by selecting appropriate behavioural change tools for the identified drivers and barriers, and developing targeted engagement strategies and messaging. Copyright © 2015 Elsevier B.V. All rights reserved.

  12. FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance a Little Less Passive.

    Science.gov (United States)

    Mann, Justin M

    2015-01-01

    Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (FAERS) is the primary system for collecting Adverse Events, but has been criticized for years for the low reporting rate into the system and the poor quality of the information submitted. This paper argues that physicians need to be required to submit adverse event reports to FAERS, because such a requirement (1) would produce a greater number of the high quality reports necessary to better determine causality; (2) is merely an extension of physicians' ethical obligations; and (3) aligns with the approach in the Vaccine Adverse Event Reporting System (VAERS). Furthermore, advances in electronic health records can aid in reporting efficiency.

  13. Data Sets Representative of the Structures and Experimental Properties of FDA-Approved Drugs.

    Science.gov (United States)

    Douguet, Dominique

    2018-03-08

    Presented here are several data sets that gather information collected from the labels of the FDA approved drugs: their molecular structures and those of the described active metabolites, their associated pharmacokinetics and pharmacodynamics data, and the history of their marketing authorization by the FDA. To date, 1852 chemical structures have been identified with a molecular weight less than 2000 of which 492 are or have active metabolites. To promote the sharing of data, the original web server was upgraded for browsing the database and downloading the data sets (http://chemoinfo.ipmc.cnrs.fr/edrug3d). It is believed that the multidimensional chemistry-oriented collections are an essential resource for a thorough analysis of the current drug chemical space. The data sets are envisioned as being used in a wide range of endeavors that include drug repurposing, drug design, privileged structures analyses, structure-activity relationship studies, and improving of absorption, distribution, metabolism, and elimination predictive models.

  14. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Science.gov (United States)

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  15. Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting.

    Science.gov (United States)

    Mandl, Kenneth D; McNabb, Marion; Marks, Norman; Weitzman, Elissa R; Kelemen, Skyler; Eggleston, Emma M; Quinn, Maryanne

    2014-01-01

    Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events. Participatory surveillance of members of a non-profit online social network, TuDiabetes.org, from October 2011 to September 2012. Subjects were volunteers from a group within TuDiabetes, actively engaged online in participatory surveillance. They used the free TuAnalyze app, a privacy-preserving method to report detailed clinical information, available through the network. Network members were polled about finger-stick blood glucose monitors, continuous glucose monitors, and insulin delivery devices, including insulin pumps and insulin pens. Of 549 participants, 75 reported device-related adverse events, nearly half (48.0%) requiring intervention from another person to manage the event. Only three (4.0%) of these were reported by participants to the FDA. All TuAnalyze reports contained outcome information compared with 22% of reports to the FDA. Hypoglycemia and hyperglycemia were experienced by 48.0% and 49.3% of participants, respectively. Members of an online community readily engaged in participatory surveillance. While polling distributed online populations does not yield generalizable, denominator-based rates, this approach can characterize risk within online communities using a bidirectional communication channel that enables reach-back and intervention. Engagement of distributed communities in social networks is a viable complementary approach to traditional public health surveillance for adverse events related to medical devices. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  16. Biomarkers of Potential Harm: Summary of an FDA-Sponsored Public Workshop.

    Science.gov (United States)

    Chang, Cindy M; Cheng, Yu-Ching; Cho, Matthew; Mishina, Elena; Del Valle-Pinero, Arseima Y; van Bemmel, Dana; Hatsukami, Dorothy K

    2017-12-14

    Since 2009, the United States (U.S.) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacture, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards. On April 4-5, 2016, FDA/CTP hosted a public workshop focused on biomarkers of potential harm (BOPH) with participants from government, industry, academia, and other organizations. The workshop was divided into five sessions focused on: 1) overview of BOPH; 2) cardiovascular disease (CVD); 3) chronic obstructive pulmonary disease (COPD); 4) cancer; and 5) new areas of research. The deliberations from the workshop noted some promising BOPH but also highlighted the lack of systematic effort to identify BOPH that would have utility and validity for evaluating tobacco products. Research areas that could further strengthen the applicability of BOPH to tobacco regulatory science include the exploration of composite biomarkers as predictors of disease risk, "omics" biomarkers, and examining biomarkers using existing cohorts, surveys and experimental studies. This paper synthesizes the main findings from the 2016 FDA-sponsored workshop focused on biomarkers of potential harm (BOPH) and highlights research areas that could further strengthen the science around BOPH and their applicability to tobacco regulatory science. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  17. The FDA Food Safety and Modernization Act and the Exemption for Small Firms

    OpenAIRE

    Pouliot, Sebastien

    2011-01-01

    The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements. This paper investigates the effects of a small firm exemption from more stringent food safety standards. The model compares food safety, total output and the number of market participants for different food safety regulation with and without an exemption for small firms. The numerical...

  18. Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation

    Science.gov (United States)

    Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.

    2017-11-01

    Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction

  19. Warnings without guidance: patient responses to an FDA warning about ezetimibe.

    Science.gov (United States)

    Shrank, William H; Choudhry, Niteesh K; Tong, Angela; Myers, Jessica; Fischer, Michael A; Swanton, Kellie; Slezak, Julie; Brennan, Troyen A; Liberman, Joshua N; Moffit, Susan; Avorn, Jerry; Carpenter, Daniel

    2012-06-01

    In January 2008, the Food and Drug Administration (FDA) communicated concerns about the efficacy of ezetimibe, but did not provide clear clinical guidance, and substantial media attention ensued. We investigated the proportion of patients who discontinued therapy and switched to a clinically appropriate alternative after the FDA communication. Using claims data from a national pharmacy benefits manager, we created a rolling cohort of new users of ezetimibe between January 2006 and August 2008 and created a supply diary for each patient in the year after cohort entry. A patient was identified as nonpersistent if a gap of 90 days was seen in the diary. Using segmented linear regression, we compared rates of nonpersistence before and after the FDA communication and assessed patient-level characteristics associated with discontinuation. Among nonpersistent patients, we determined whether a patient made a clinically appropriate switch in the subsequent 90 days by adding a new cholesterol-lowering medication or by increasing the dose of an existing one. We used a weighted t test to compare the rates of appropriate switching before and after the communication. Among 867,027 new ezetimibe users, 407,006 (46.9%) were nonpersistent in the first year. After the FDA communication, the monthly level of ezetimibe nonpersistence increased by 5.7 percentage points (Pcommunication regarding its efficacy and following associated media attention, and a small proportion of patients made a clinically appropriate switch after discontinuation. Further consideration is needed to deliver messages that promote appropriate use of chronic therapy rather than simply reduce use.

  20. Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

    Directory of Open Access Journals (Sweden)

    Benjamin Hixon

    2017-02-01

    Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

  1. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12

    Science.gov (United States)

    Trumbo, Paula R

    2016-01-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

  2. Metabolic and hormonal alterations in cats with hepatic lipidosis.

    Science.gov (United States)

    Brown, B; Mauldin, G E; Armstrong, J; Moroff, S D; Mauldin, G N

    2000-01-01

    Hepatic lipidosis in cats is a commonly diagnosed hepatobiliary disease of unknown cause. The purpose of this prospective study was to characterize the blood hormone and lipid status of cats with hepatic lipidosis, and to compare this status to that of cats with other types of liver disease and to control cats. Twenty-three cats with hepatic disease were assigned to 1 of 2 groups on the basis of cytopathologic or histopathologic examination of the liver: group 1, hepatic lipidosis (n = 18); or group 2, cholangiohepatitis (n = 5). Ten healthy young adult cats were used as controls. Food was withheld from control animals for 24 hours before blood collection. Concentrations of plasma glucagon and serum insulin, cortisol, thyroxine, triglycerides, cholesterol, phospholipids, and nonesterified fatty acids (NEFAs) were determined in all cats, in addition to routine hematologic and serum biochemical testing. Cats with hepatic lipidosis had higher serum NEFA concentrations than cats with cholangiohepatitis or control cats (P lipidosis or control cats (P lipidosis. Serum insulin concentrations were significantly higher in control cats than in diseased cats (P lipidosis suggests that at least 1 factor in the pathogenesis of this syndrome may involve the regulation of hormone-sensitive lipase.

  3. Surrenderers’ Relationships with Cats Admitted to Four Australian Animal Shelters

    Directory of Open Access Journals (Sweden)

    Sarah Zito

    2018-02-01

    Full Text Available The surrender of cats to animal shelters results in financial, social and moral burdens for the community. Correlations of caretaking and interactions with surrendered cats were calculated, to understand more about humans’ relationships with surrendered cats and the contribution of semi-owned cats to shelter intakes. A questionnaire was used to collect detailed information about 100 surrenderers’ relationships with cats they surrendered to four animal shelters in Australia, with each surrenderer classifying themselves as being either the owner or a non-owner of the surrendered cat (ownership perception. Method of acquisition of the cat, association time, closeness of the relationship with the cat and degree of responsibility for the cat’s care were all associated with ownership perception. Many non-owners (59% fed and interacted with the cat they surrendered but rarely displayed other caretaking behaviours. However, most surrenderers of owned and unowned cats were attached to and felt responsible for the cat. Based on these results and other evidence, a causal model of ownership perception was proposed to provide a better understanding of factors influencing ownership perception. This model consisted of a set of variables proposed as directly or indirectly influencing ownership perception, with connecting arrows to indicate proposed causal relationships. Understanding ownership perception and the contribution of semi-owned cats to shelter intake is important as these can inform the development of more targeted and effective intervention strategies to reduce numbers of unwanted cats.

  4. Osteosarcoma in cats: 22 cases (1974-1984)

    International Nuclear Information System (INIS)

    Bitetto, W.V.; Patnaik, A.K.; Schrader, S.C.; Mooney, S.C.

    1987-01-01

    Osteosarcoma was diagnosed in 22 cats. Diagnosis was based on results of physical, radiographic, and histologic findings. Fifteen tumors arose from the appendicular skeleton, 4 from the skull, 2 from the pelvis, and 1 from a rib. Radiography revealed that in 14 of 15 cats (93%) with appendicular tumors, the lesion was metaphyseal, primarily lytic, with a ''moth-eaten'' appearance; absence and presence of periosteal new bone formation were associated with the tumors in 12 and 3 cats, respectively. The remaining 7 cats had axial tumors that were characterized by the presence of periosteal new bone formation in addition to bony lysis. Of the 15 cats with appendicular tumors, 12 were treated by amputation and 3 were euthanatized at the time of diagnosis. Of the cats undergoing amputation for treatment of their appendicular tumors, 6 cats were still alive 64 months after surgery (range, 13 to 64 months); the median survival time of the 5 cats (1 cat was lost to follow-up evaluation) that died was 49.2 months (range, 1 to 122 months). Four of 12 cats (33%) survived greater than or equal to 5 years after diagnosis. Of the cats with axial tumors that were not euthanatized at the time of diagnosis (6 of 7), the median survival time was 5.5 months. Based on these findings, we concluded that cats with appendicular osteosarcoma have a better prognosis than those with axial osteosarcoma, and that amputation is a viable treatment for cats with appendicular osteosarcoma

  5. CATS Aerosol Typing and Future Directions

    Science.gov (United States)

    McGill, Matt; Yorks, John; Scott, Stan; Palm, Stephen; Hlavka, Dennis; Hart, William; Nowottnick, Ed; Selmer, Patrick; Kupchock, Andrew; Midzak, Natalie; hide

    2016-01-01

    The Cloud Aerosol Transport System (CATS), launched in January of 2015, is a lidar remote sensing instrument that will provide range-resolved profile measurements of atmospheric aerosols and clouds from the International Space Station (ISS). CATS is intended to operate on-orbit for at least six months, and up to three years. Status of CATS Level 2 and Plans for the Future:Version. 1. Aerosol Typing (ongoing): Mode 1: L1B data released later this summer; L2 data released shortly after; Identify algorithm biases (ex. striping, FOV (field of view) biases). Mode 2: Processed Released Currently working on correcting algorithm issues. Version 2 Aerosol Typing (Fall, 2016): Implementation of version 1 modifications Integrate GEOS-5 aerosols for typing guidance for non spherical aerosols. Version 3 Aerosol Typing (2017): Implementation of 1-D Var Assimilation into GEOS-5 Dynamic lidar ratio that will evolve in conjunction with simulated aerosol mixtures.

  6. Dacryocystography in a cat with orbital pneumatosis.

    Science.gov (United States)

    Meomartino, Leonardo; Pasolini, Maria P; Lamagna, Francesco; Santangelo, Bruna; Mennonna, Giuseppina; Della Valle, Giovanni; Lamagna, Barbara

    2015-03-01

    A 2-year-old neutered male European short-haired cat was presented for a persistent discharge from the scar of previous left eye enucleation, performed 6 months prior by the referring veterinarian. A surgical exploration of the orbit was performed and retained nictitating membrane glandular and conjunctival tissues were removed. Eleven days later, the cat developed an orbital pneumatosis caused by retrograde movement of air through a patent nasolacrimal system and diagnosed by survey radiographic examination of the skull. Nasolacrimal system patency was assessed by dacryocystography performed by injection of iodinated contrast medium under pressure into the orbital cavity. Computed tomography dacryocystography confirmed the radiographic findings. The condition resolved following dacryocystography, possibly as an inflammatory response to the contrast medium. To our knowledge, this is the first case of orbital pneumatosis reported in a cat. © 2013 American College of Veterinary Ophthalmologists.

  7. Central tarsal bone fracture in a cat.

    Science.gov (United States)

    Cinti, Filippo; Pisani, Guido; Penazzi, Claudio; Carusi, Umberto; Vezzoni, Luca; Vezzoni, Aldo

    2016-01-01

    Fracture of the central tarsal bone is an uncommon injury in dogs and occurs predominantly in racing Greyhounds. To the authors' knowledge, this type of fracture has not been described previously in cats. This case report describes a five-year-old Domestic Shorthair cat referred to the Centro Veterinario Luni Mare because of lameness, swelling and signs of pain in the right hindlimb caused by trauma. Clinical examination and diagnostic imaging revealed a right central tarsal bone fracture. Open reduction and internal fixation with a 2.0 mm position screw and two 0.8 mm Kirschner wires were carried out. The last follow-up examination three years postoperatively found the cat in good health with normal range of motion and function, and no signs of lameness in the right hindlimb.

  8. Dilated cardiomyopathy in cats - A case report

    Directory of Open Access Journals (Sweden)

    K. Jeyaraja

    2013-08-01

    Full Text Available Two cats were brought to Madras Veterinary College Teaching Hospital with the history and clinical signs suggestive of congestive heart failure ie, coughing, exercise intolerance, dyspnea, abdominal distension etc. There was history of feeding the cat with home made diet in one case and in other with commercial dog food. Based on electrocardiographic, radiographic and echocardiographic findings, the diagnosis of dilated cardiomyopathy was done in both the cases. The cases were managed with enalapril maleate, furosemide, dietary taurine supplementation and other supportive therapy. Among these two cases, one cat died on 2nd day of treatment and the other showed recovery after 8 days of treatment. [Vet World 2013; 6(4.000: 226-227

  9. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation

    Science.gov (United States)

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-01-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA’s authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. PMID:25550419

  10. Biomarkers of Tobacco Exposure: Summary of an FDA-Sponsored Public Workshop.

    Science.gov (United States)

    Chang, Cindy M; Edwards, Selvin H; Arab, Aarthi; Del Valle-Pinero, Arseima Y; Yang, Ling; Hatsukami, Dorothy K

    2017-03-01

    Since 2009, the FDA Center for Tobacco Products (CTP) has had the authority to regulate the manufacturing, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers of exposure pertain to actual human exposure to chemicals arising from tobacco use and could play an important role across a number of FDA regulatory activities, including assessing new and modified-risk tobacco products and identifying and evaluating potential product standards. On August 3-4, 2015, FDA/CTP hosted a public workshop focused on biomarkers of exposure with participants from government, industry, academia, and other organizations. The workshop was divided into four sessions focused on: (i) approaches to evaluating and selecting biomarkers; (ii) biomarkers of exposure and relationship to disease risk; (iii) currently used biomarkers of exposure and biomarkers in development; and (iv) biomarkers of exposure and the assessment of smokeless tobacco and electronic nicotine delivery systems. This article synthesizes the main findings from the workshop and highlights research areas that could further strengthen the science around biomarkers of exposure and help determine their application in tobacco product regulation. Cancer Epidemiol Biomarkers Prev; 26(3); 291-302. ©2016 AACR . ©2016 American Association for Cancer Research.

  11. Regulatory administrative databases in FDA's Center for Biologics Evaluation and Research: convergence toward a unified database.

    Science.gov (United States)

    Smith, Jeffrey K

    2013-04-01

    Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.

  12. New and incremental FDA black box warnings from 2008 to 2015.

    Science.gov (United States)

    Solotke, Michael T; Dhruva, Sanket S; Downing, Nicholas S; Shah, Nilay D; Ross, Joseph S

    2018-02-01

    The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.

  13. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.

    Science.gov (United States)

    Mehta, Mehul U; Uppoor, Ramana S; Conner, Dale P; Seo, Paul; Vaidyanathan, Jayabharathi; Volpe, Donna A; Stier, Ethan; Chilukuri, Dakshina; Dorantes, Angelica; Ghosh, Tapash; Mandula, Haritha; Raines, Kimberly; Dhanormchitphong, Pariban; Woodcock, Janet; Yu, Lawrence X

    2017-12-04

    The FDA guidance on application of the biopharmaceutics classification system (BCS) for waiver of in vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created worldwide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry toward its implementation and further expansion. This article describes how the review implementation of this guidance was undertaken at the FDA and results of these efforts over last dozen years or so across the new, and the generic, drug domains are provided. Results show that greater than 160 applications were approved, or tentatively approved, based on the BCS approach across multiple therapeutic areas; an additional significant finding was that at least 50% of these approvals were in the central nervous system (CNS) area. These findings indicate a robust utilization of the BCS approach toward reducing unnecessary in vivo BE studies and speeding up availability of high quality pharmaceutical products. The article concludes with a look at the adoption of this framework by regulatory and health policy organizations across the globe, and FDA's current thinking on areas of improvement of this guidance.

  14. An Improved Adaptive Received Beamforming for Nested Frequency Offset and Nested Array FDA-MIMO Radar

    Directory of Open Access Journals (Sweden)

    Sibei Cheng

    2018-02-01

    Full Text Available For the conventional FDA-MIMO (frequency diversity array multiple-input-multiple-output Radar with uniform frequency offset and uniform linear array, the DOFs (degrees of freedom of the adaptive beamformer are limited by the number of elements. A better performance—for example, a better suppression for strong interferences and a more desirable trade-off between the main lobe and side lobe—can be achieved with a greater number of DOFs. In order to obtain larger DOFs, this paper researches the signal model of the FDA-MIMO Radar with nested frequency offset and nested array, then proposes an improved adaptive beamforming method that uses the augmented matrix instead of the covariance matrix to calculate the optimum weight vectors and can be used to improve the output performances of FDA-MIMO Radar with the same element number or reduce the element number while maintain the approximate output performances such as the received beampattern, the main lobe width, side lobe depths and the output SINR (signal-to-interference-noise ratio. The effectiveness of the proposed scheme is verified by simulations.

  15. Effects of FDA advisories on the pharmacologic treatment of ADHD, 2004-2008.

    Science.gov (United States)

    Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S; Conti, Rena M; Dusetzina, Stacie B; Garfield, Craig F; Dorsey, E Ray; Huskamp, Haiden A; Alexander, G Caleb

    2013-04-01

    This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies-clonidine, guanfacine, and bupropion-was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit.

  16. Effects of FDA Advisories on the Pharmacologic Treatment of ADHD, 2004–2008

    Science.gov (United States)

    Kornfield, Rachel; Watson, Sydeaka; Higashi, Ashley S.; Conti, Rena M.; Dusetzina, Stacie B.; Garfield, Craig F.; Dorsey, E. Ray; Huskamp, Haiden A.; Alexander, G. Caleb

    2014-01-01

    Objective This study assessed the effect of public health advisories issued between 2005 and 2007 by the U.S. Food and Drug Administration (FDA) on treatments of attention-deficit hyperactivity disorder (ADHD) and physician prescribing practices. Methods Data obtained from the IMS Health National Disease and Therapeutic Index, a nationally representative audit of ambulatory physicians, were used to examine trends in office visits by children and adolescents (under age 18) during which ADHD was treated with Adderall, other psychostimulants, or atomoxetine. Segmented time series regressions were conducted to determine changes in use associated with three advisories issued between 2005 and 2007. Results In 2004, before the first FDA advisory, Adderall accounted for 36% of ADHD pharmacotherapy treatment visits. Other stimulants accounted for 46%, and atomoxetine accounted for 19%. Overall pharmacotherapy treatment rates were stable over the study period, but by 2008 the treatment visits accounted for by Adderall (that is, market share) declined to 24%, and the market share for atomoxetine declined to 8%. The market share for substitute therapies—clonidine, guanfacine, and bupropion—was stable over this period, ranging from 5% to 7%. Despite the declines in the use of Adderall and atomoxetine over the study period, results from the regression models suggest that the advisories did not have a statistically significant effect on ADHD medication prescribing. Conclusions FDA advisories regarding potential cardiovascular and other risks of ADHD medications had little discernible incremental effect on the use of these medicines in this nationally representative ambulatory audit. PMID:23318985

  17. FDA Approval of PARP Inhibitors and the Impact on Genetic Counseling and Genetic Testing Practices.

    Science.gov (United States)

    Buchtel, Kathryn M; Vogel Postula, Kristen J; Weiss, Shelly; Williams, Carmen; Pineda, Mario; Weissman, Scott M

    2018-02-01

    In December 2014, the FDA approved olaparib, a poly(ADP-ribose) polymerase inhibitor (PARPi) for ovarian cancer patients who have failed three or more lines of chemotherapy and have a germline BRCA1/2 mutation identified through a companion diagnostic test (BRACAnalysis CDx™ (CDx™)) offered exclusively by Myriad Genetic Laboratories. This study explored the impact of PARPi/CDx™ on genetic counselors' (GCs) counseling and testing practices. One hundred twenty three GCs responded to an online survey regarding pre- and post-FDA approval referral patterns, testing strategies/influences, and anecdotal experiences with insurance coverage of PARPi for BRCA1/2 positive patients through a non-CDx™ platform. Following PARPi approval, 40% of respondents reported an increase in overall referrals of ovarian cancer patients and 20% had an increase in post-test counseling only referrals. The majority (61.9%) of respondents reported no change in genetic testing strategy, and there was no change in factors influencing choice of testing laboratory. Nearly all (98.1%) respondents who had experience with insurance covering PARPi indicated approval with mutations identified via non-CDx™ testing. Respondents indicated an increase in referral volume following FDA approval of PARPi/CDx™, but did not report changes in testing practices. Respondents were not aware of PARPi insurance coverage denial in the absence of CDx™.

  18. Astaxanthin uptake in domestic dogs and cats

    Directory of Open Access Journals (Sweden)

    Massimino Stefan

    2010-06-01

    Full Text Available Abstract Background Research on the uptake and transport of astaxanthin is lacking in most species. We studied the uptake of astaxanthin by plasma, lipoproteins and leukocytes in domestic dogs and cats. Methods Mature female Beagle dogs (18 to 19 mo old; 11 to 14 kg BW were dosed orally with 0, 0.1, 0.5, 2.5, 10 or 40 mg astaxanthin and blood taken at 0, 3, 6, 9, 12, 18 and 24 h post-administration (n = 8/treatment. Similarly, mature domestic short hair cats (12 mo old; 3 to 3.5 kg body weight were fed a single dose of 0, 0.02, 0.08, 0.4, 2, 5, or 10 mg astaxanthin and blood taken (n = 8/treatment at the same interval. Results Both dogs and cats showed similar biokinetic profiles. Maximal astaxanthin concentration in plasma was approximately 0.14 μmol/L in both species, and was observed at 6 h post-dosing. The plasma astaxanthin elimination half-life was 9 to 18 h. Astaxanthin was still detectable by 24 h in both species. In a subsequent study, dogs and cats were fed similar doses of astaxanthin daily for 15 to 16 d and astaxanthin uptake by plasma, lipoproteins, and leukocytes studied. In both species, plasma astaxanthin concentrations generally continued to increase through d 15 or 16 of supplementation. The astaxanthin was mainly associated with high density lipoprotein (HDL. In blood leukocytes, approximately half of the total astaxanthin was found in the mitochondria, with significant amounts also associated with the microsomes and nuclei. Conclusion Dogs and cats absorb astaxanthin from the diet. In the blood, the astaxanthin is mainly associated with HDL, and is taken up by blood leukocytes, where it is distributed to all subcellular organelles. Certain aspects of the biokinetic uptake of astaxanthin in dogs and cats are similar to that in humans.

  19. Laryngeal disease in dogs and cats.

    Science.gov (United States)

    Macphail, Catriona

    2014-01-01

    The most common disease process involving the larynx is laryngeal paralysis, which occurs much more frequently in dogs than in cats. Diagnosis of laryngeal paralysis requires close attention to anesthetic plane and coordination of respiratory effort with laryngeal motion. Surgical arytenoid lateralization improves respiration and quality of life in dogs with laryngeal paralysis; however, aspiration pneumonia is a recognized complication, and generalized neuropathy can progress. Laryngeal collapse can result from any cause of chronic upper airway obstruction, but is most often associated with unaddressed brachycephalic airway syndrome. Laryngeal neoplasia, while generally uncommon, occurs more frequently in cats than in dogs. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. Septic lens implantation syndrome in a cat.

    Science.gov (United States)

    Dalesandro, Nicole; Stiles, Jean; Miller, Margaret

    2011-09-01

    A 13-year-old female spayed domestic shorthair cat was presented initially for a change in the appearance of the left eye. On initial examination, a small penetrating wound was suspected as the cause for a corneal scar, an anterior cortical incipient cataract and mild iritis. The cat was not re-presented until 1 year later at which time ocular pain was marked. Severe anterior uveitis and glaucoma were diagnosed and the eye enucleated. Histopathology documented intralenticular coccoid bacteria and septic lens implantation syndrome. © 2011 American College of Veterinary Ophthalmologists.

  1. The prognostic biomarker L-homoarginine is a substrate of the cationic amino acid transporters CAT1, CAT2A and CAT2B.

    Science.gov (United States)

    Chafai, Anja; Fromm, Martin F; König, Jörg; Maas, Renke

    2017-07-06

    Low plasma concentration of L-homoarginine is an independent predictor of cardiovascular events and total mortality. Experimental data indicate that supplementation of L-homoarginine may have protective effects. We aimed to elucidate the mechanisms involved in the cellular uptake of L-homoarginine, which are little understood, so far. Using human embryonic kidney (HEK293) cell lines stably overexpressing the human cationic amino acid transporters CAT1 [solute carrier family 7 (SLC7A1)], CAT2A (SLC7A2A) or CAT2B (SLC7A2B) we assessed the transport kinetics of L-homoarginine and interactions with the CAT substrates L-arginine and asymmetric dimethylarginine (ADMA). Significant uptake of L-homoarginine was observed for all three CATs with apparent K M -values of 175 ± 7 µM for CAT1 and 523 ± 35 µM for CAT2B. Saturation of CAT2A-mediated L-homoarginine uptake could not be reached. Uptake of L-homoarginine by any of the three CATs could be inhibited by L-arginine and ADMA. Significant inhibition of CAT1-mediated uptake of L-homoarginine by L-arginine already occurred in the physiological concentration range. Taken together these data demonstrate that L-homoarginine is a substrate of CAT1, CAT2A and CAT2B and that CAT1 is a key site with regard to physiological relevance and interactions with related substrates such as L-arginine.

  2. Transmission of feline immunodeficiency virus (FIV) among cohabiting cats in two cat rescue shelters.

    Science.gov (United States)

    Litster, Annette L

    2014-08-01

    Conflicting accounts have been published in the veterinary literature regarding transmission of feline immunodeficiency virus (FIV) between cohabiting cats in mixed households, and the mechanics of possible casual transmission, if it occurs, are poorly understood. Similarly, there are conflicting reports of vertical transmission of FIV. The aim of the present study was to document the FIV serological status of cats taken into two rescue shelters. At rescue shelter 1 (Rescue 1), cats cohabited in a multi-cat household of FIV-negative and naturally-infected, FIV-positive cats. A study was performed that combined a retrospective review of records of FIV serological status at intake (Test 1) and prospective FIV serological testing (Tests 2 and 3). Retrospective records were analyzed at rescue shelter 2 (Rescue 2), where FIV-positive queens with litters of nursing kittens were taken into the shelter, before being rehomed. FIV serology was performed on all kittens after weaning. Initial test results (Test 1) for 138 cohabiting cats from Rescue 1 showed that there were 130 FIV-negative cats and eight FIV-positive cats (six male neutered and two female spayed). A second test (Test 2), performed in 45 of the FIV-negative and five of the FIV-positive cats at median 28 months after Test 1 (range, 1 month to 8.8 years) showed that results were unchanged. Similarly, a third test (Test 3), performed in four of the original FeLV-negative cats and one remaining FIV-positive cat at median 38 months after Test 1 (range, 4 months to 4 years), also showed that results were unchanged. These results show a lack of evidence of FIV transmission, despite years of exposure to naturally-infected, FIV-positive cats in a mixed household. At Rescue 2, records were available from five FIV-positive queens with 19 kittens. All 19 kittens tested FIV-negative, suggesting that vertical transmission had not occurred. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Determinants of Cat Choice and Outcomes for Adult Cats and Kittens Adopted from an Australian Animal Shelter.

    Science.gov (United States)

    Zito, Sarah; Paterson, Mandy; Vankan, Dianne; Morton, John; Bennett, Pauleen; Phillips, Clive

    2015-04-29

    The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters' cat age group choice (adult or kitten) and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6-12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of "low-cost" adoptions in populations, such as the study population, and lends support for the use of "low-cost" adoptions as an option for attempting to increase adoption rates. In addition, the results provide information that can be used to inform future campaigns aimed at increasing the number of adult cat adoptions, particularly in devising marketing strategies for adult cats.

  4. FDA MAUDE data on complications with lasers, light sources, and energy-based devices.

    Science.gov (United States)

    Tremaine, Anne Marie; Avram, Mathew M

    2015-02-01

    It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional

  5. Guidelines for vaccination of dogs and cats in Korea.

    Science.gov (United States)

    Song, Woo-Jin; Kim, Hyun-Tae; Yoo, Han-Sang; Youn, Hwa-Young

    2014-07-01

    This guideline contains the recommended vaccination schedules of dogs and cats from World Small Animal Veterinary Association (WSAVA) and American Animal Hospital Association (AAHA). In 2010, WSAVA published guidelines for the vaccination of dogs and cats. And, in 2011, AAHA also published guidelines for vaccination of dogs. In Korea, there is no published guideline for vaccination of dogs and cats yet. Therefore, the plane of vaccination also reports the present situation of vaccination schedule of dogs and cats in Korean animal hospitals.

  6. [Mycoplasma sp. isolation in sick and normal cats (author's transl)].

    Science.gov (United States)

    Campedelli Filho, O

    1977-01-01

    This paper deals with the presence of mycoplasmosis in sick and normal cats lodged by U.I.P.A. (União Internacional de Proteçäo aos Animais) São Paulo, Brazil. In a group of 78 cats, 10.41% of mycoplasma was found in sick cats and 0% in normal cats, in a total of 6,41% of positive cases.

  7. Toxocara cati infections in domestic cats from two communities in ...

    African Journals Online (AJOL)

    An epidemiological survey was undertaken to study the prevalence and intensity of infection with Toxocara cati in some selected domestic cats from two communities in south-western Nigeria. Faecal samples of 200 cats were collected through a direct rectal swab using a long forceps from households with cat from Ode Irele ...

  8. Seroprevalence of Toxoplasma gondii in cats from Colombo, Sri Lanka

    Science.gov (United States)

    Cats are essential in the life cycle of Toxoplasma gondii because they are the only hosts that can excrete the environmentally-resistant oocysts in nature. Nothing is known of the prevalence of Toxoplasma gondii in cats from Sri Lanka. Serum samples from 86 cats from Colombo, Sri Lanka were tested f...

  9. Gallbladder mucocoele and concurrent hepatic lipidosis in a cat.

    Science.gov (United States)

    Bennett, S L; Milne, M; Slocombe, R F; Landon, B P

    2007-10-01

    A 3-year-old Domestic Shorthair cat was presented with weight loss, anorexia and icterus. Feline hepatic lipidosis and gallbladder mucocoele were diagnosed; this is the first report of gallbladder mucocoele in the cat. The case was managed successfully with cholecystojejunostomy, gastrostomy tube placement and tube feeding for 3 months. The cat has survived over the long term with minimal complications.

  10. Lungworm disease in cats : ABCD guidelines on prevention and management

    NARCIS (Netherlands)

    Pennisi, Maria Grazia; Hartmann, Katrin; Addie, Diane D; Boucraut-Baralon, Corine; Egberink, Herman; Frymus, Tadeusz; Gruffydd-Jones, Tim; Horzinek, Marian C; Hosie, Margaret J; Lloret, Albert; Lutz, Hans; Marsilio, Fulvio; Radford, Alan D; Thiry, Etienne; Truyen, Uwe; Möstl, Karin

    OVERVIEW: Cardiopulmonary nematodes are emerging parasites of cats in Europe. A number of helminth parasites may be involved. The most prevalent lungworm in domestic cats is Aelurostrongylus abstrusus. Oslerus rostratus and Troglostrongylus species are found mainly in wild cats. The trichurid

  11. The effect of cat Felis catus predation on three breeding ...

    African Journals Online (AJOL)

    Breeding success of Pterodroma macroptera, Procellaria aequinoctialis and Pachyptila vittata salvini in three cat-free and three control areas were used to evaluate the effects of cat Felis catus predation on the avifauna of Marion Island. Breeding success of all three species was significantly higher in the combined cat-free ...

  12. Detection of Vaccinia Virus in Urban Domestic Cats, Brazil.

    Science.gov (United States)

    Costa, Galileu Barbosa; Miranda, Júlia Bahia; Almeida, Gregório Guilherme; Silva de Oliveira, Jaqueline; Pinheiro, Mariana Siqueira; Gonçalves, Stefanne Aparecida; Pimenta Dos Reis, Jenner Karlisson; Gonçalves, Ricardo; Ferreira, Paulo César Peregrino; Bonjardim, Cláudio Antônio; Abrahão, Jônatas Santos; Kroon, Erna Geessien; Trindade, Giliane de Souza

    2017-02-01

    We investigated possible vaccinia virus (VACV) in urban house cats in Brazil. Serum samples from 6 cats were positive for VACV by PCR, indicating likely VACV circulation among house cats in urban areas of Brazil. This finding highlights the importance of epidemiologic surveillance to avoid outbreaks among urban human populations.

  13. 50 CFR 28.43 - Destruction of dogs and cats.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Destruction of dogs and cats. 28.43 Section 28.43 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR... VIOLATIONS OF PARTS 25, 26, AND 27 Impoundment Procedures § 28.43 Destruction of dogs and cats. Dogs and cats...

  14. Purified natural and recombinant Fel d 1 and cat albumin in in vitro diagnostics for cat allergy

    NARCIS (Netherlands)

    van Ree, R.; van Leeuwen, W. A.; Bulder, I.; Bond, J.; Aalberse, R. C.

    1999-01-01

    Current diagnostics and therapeutics for cat allergy are based on cat epithelial extracts originating from highly variable source materials. This gives rise to several problems: variability of allergen composition, contamination with house dust mite allergens, and potential transfer of pathogenic

  15. Digital flexor musculotendinous contracture in two Devon Rex cats.

    Science.gov (United States)

    Thom, Leonie K; Pool, Roy R; Malik, Richard

    2017-03-01

    Clinical summary: A 13-year-old, spayed Devon Rex with unilateral digital flexor musculotendinous contracture of the forelimb was treated by surgical tenotomy. The condition improved transiently, but recurred rapidly and became bilateral. Histopathologic analysis of necropsy tissues resulted in a morphologic diagnosis of fibromyositis of the antebrachial muscles causing contracture and flexural deformity of the carpi and phalanges of both thoracic limbs. A search for similar cases yielded the clinical notes of a second cat, a 10-year-old, spayed Devon Rex, also with bilateral disease. This second case responded well to surgical tenotomy but tissue biopsies were not obtained to permit microscopic assessment of the underlying pathologic process. Relevance and novel information: Acquired and permanent contracture of the digital flexor muscles and/or tendons of the forelimbs is a rare and poorly described condition of cats. The very limited number of documented cases describing disease affecting one or more digits (but not the carpus) infers a causal link with onychectomy, but reported histopathologic changes have been limited to the tendons. The two cases described in this report suffered contracture of the carpus and all digits bilaterally, one without previous onychectomy and the other 9 years after onychectomy. There were novel histopathologic findings in the muscles of the one case for which biopsy material was available. Information gained from these two cases provides a new perspective for the investigation and treatment of future cases. Specifically, consideration should be given to an underlying immune-mediated myopathic process and a possible genetic predisposition in the Devon Rex breed. Currently, the poorly understood etiopathogenesis hinders our ability to definitively recommend treatment options, which might include corticosteroids and other forms of immunosuppressive therapy.

  16. COMPARISON OF PBDES IN CAT SERUM TO LEVELS IN CAT FOOD: EVIDENCE OF DECA DEBROMINATION?

    Science.gov (United States)

    Abstract Since the introduction of brominated flame retardants (such as the PBDEs), increases in feline hyperthyroidism have been observed. We hypothesized that PBDE exposure was linked to the increased occurrence of hyperthyroidism in cats. Herein, PBDEs in serum of pet ...

  17. Evaluating "Cat Country": The Humor within Satire

    Science.gov (United States)

    Chang, Chung-chien Karen

    2010-01-01

    Satire, as a mode, is not frequently employed in Chinese narratives. "Cat Country," or "Mao Cheng Ji," written by Lao She (pen name of Shu Qing Chun, 1898--1966) has come under much attack of its literary values. Whereas most critics have no doubt that this work sets out to satirize China through the portrayal of a society of…

  18. Nutrition and oxalate metabolism in cats

    NARCIS (Netherlands)

    Dijcker, J.C.|info:eu-repo/dai/nl/315029412

    2013-01-01

    Over the past 30 years, a progressive increase in calcium oxalate (CaOx) urolith prevalence is reported in cats and dogs diagnosed with urolithiasis. This increase in prevalence appears to have occurred since dietary modifications were introduced to address magnesium ammonium phosphate urolithiasis.

  19. Phenotypic variability of cat-eye syndrome

    NARCIS (Netherlands)

    Berends, MJW; Tan-Sindhunata, G; Leegte, B; Van Essen, AJ

    2001-01-01

    Cat-Eye syndrome (CES) is a disorder with a variable pattern of multiple congenital anomalies of which coloboma of the iris and anal atresia are the best known. CES is cyogenetically characterised by the presence of an extra bisatellited marker chromosome, which represents an inverted dicentric

  20. Dermatophilus congolensis in a feral cat.

    Science.gov (United States)

    Barger, Anne M; Weedon, G Robert; Maddox, Carol W; Galloway, Kimberly A

    2014-10-01

    A young adult feral cat presented to the Champaign County Humane Society with a subcutaneous mass near the stifle. The mass was aspirated. Chains of paired cocci organisms were identified, consistent with Dermatophilus congolensis. The identity of these organisms was confirmed by culture and polymerase chain reaction. © ISFM and AAFP 2014.

  1. Design of a Competency Administration Toolset (CAT)

    Science.gov (United States)

    2017-03-01

    nor well integrated . The stakeholder competency’s Budget Financial Managers (BFMs) used two independent data repositories, including Navy Enterprise... report , all objectives have been met. Confirmation from all levels of the stakeholder representatives indicated that Team CAT successfully met the...NAVAL POSTGRADUATE SCHOOL MONTEREY, CALIFORNIA SYSTEMS ENGINEERING CAPSTONE PROJECT REPORT Approved for public release

  2. Getting a CAT Scan (For Kids)

    Medline Plus

    Full Text Available ... Answers (Q&A) Staying Safe Videos for Educators Search English Español Getting a CAT Scan (Video) KidsHealth / ... Nondiscrimination Visit the Nemours Web site. Note: All information on KidsHealth® is for educational purposes only. For ...

  3. Renal abscesses in cats: six cases.

    Science.gov (United States)

    Faucher, Mathieu R; Theron, Marie-Laure; Reynolds, Brice S

    2017-04-01

    Case series summary Six cats were diagnosed with renal abscesses. Common clinical findings were lethargy, dehydration, abdominal pain and nephromegaly. Fever was noted in half of the cases. Diagnosis was established by ultrasonography, cytological examination and bacterial culture of abscess aspirates. At least one possible contributing factor could be identified in all cases. Antibiotics were consistently used and in two cats the abscess was surgically drained. The short-term outcome was fair but the long-term outcome was dependent on the underlying condition. Relevance and novel information The results of this small case series suggest that renal abscess should be considered when nephromegaly and/or abdominal discomfort are noted. Diagnosis of renal abscess is straightforward when ultrasonography and fine-needle aspirate analysis can be performed. Medical treatment is assumed to be preferable but surgical treatment may be warranted on a case-by-case basis. Given that almost every affected cat was diagnosed with at least one comorbidity, a thorough evaluation is recommended for all cats with renal abscesses.

  4. Daffodil toxicosis in an adult cat

    OpenAIRE

    Saxon-Buri, Sharon

    2004-01-01

    A domestic longhair cat with a 3-day history of lethargy and vomiting after ingesting dried daffodil stems (Narcissus spp.) was severely hypothermic (33.0°C), with bradycardia (78 beats/min) and hypotension. Treatment with atropine, dexamethasone, fluid therapy, and supportive care resulted in a complete recovery by 6 days after exposure.

  5. Benign cementoblastoma (true cementoma in a cat

    Directory of Open Access Journals (Sweden)

    Lenin A Villamizar-Martinez

    2016-01-01

    Full Text Available Case summary A 10-year-old castrated male domestic shorthair cat was presented for assessment of a gingival mass surrounding the left maxillary third and fourth premolar teeth. The mass was surgically removed by means of a marginal rim excision, and the tissue was submitted for histological assessment. It was identified as a benign cementoblastoma (true cementoma. There was proliferation of mineralized eosinophilic material with multiple irregularly placed lacunae and reversal lines, reminiscent of cementum. The cat recovered uneventfully from the anesthesia, and there was no evidence of tumor recurrence 6 months after surgery. Relevance and novel information Cementoblastomas (true cementomas in domestic animals are rare, with just a few reports in ruminants, monogastric herbivores and rodents. Cementoblastoma is considered a benign tumor that arises from the tooth root. The slow, expansive and constant growth that characterizes these masses may be accompanied by signs of oral discomfort and dysphagia. This case report is intended to increase knowledge regarding this tumor in cats and also highlights the importance of complete excision of the neoplasm. To our knowledge, there are no previous reports in the literature of cementoblastoma in the cat.

  6. Veterinarian Gets Flu Virus from Cats

    Centers for Disease Control (CDC) Podcasts

    2018-03-28

    Dr. Todd Davis, a CDC research biologist, discusses transmission of avian H7N2 from a cat to a human.  Created: 3/28/2018 by National Center for Emerging and Zoonotic Infectious Diseases (NCEZID).   Date Released: 3/28/2018.

  7. Suppression of fertility in adult cats

    DEFF Research Database (Denmark)

    Goericke-Pesch, Sandra Kathrin; Wehrend, A.; Georgiev, P.

    2014-01-01

    and clinical options are available for the suppression of fertility in adult cats and the decision as to which should be chosen - independent of the legal registration of any state - depends on different facts: (i) feral or privately owned animal? (ii) temporary or permanent suppression of fertility wanted...

  8. The antihypertensive effect of amlodipine in cats

    Directory of Open Access Journals (Sweden)

    D. Morar,

    2011-06-01

    Full Text Available The purpose of the study was to evaluate the effect of amlodipine on blood pressure and renal function in cats with arterial hypertension secondary to chronic renal failure. The research was conducted on 11 cats, aged between 7 and 14.5 years, diagnosed with arterial hypertension secondary to chronic renal failure. Systolic blood pressure (SBP, diastolic blood pressure (DBP, mean arterial pressure (MBP and pulse rate were determined by oscillometric method, before and after 7, 30 or 120 days of treatment with amlodipine. At the beginning of treatment, all cats were receiving 0.625 mg amlodipine once daily and after 7 days oftreatment, in five cats, the dose was increased to 1.25 mg amlodipine, once daily. Before amlodipine administration the mean values of SBP/DBP were 175 ± 13.2 mmHg/119 ± 7.2 mmHg and after 30 days of treatment, the mean values of the SBP/DBP were reduced by 27.9/25.4 mmHg (p<0,001. After 120 days of treatment with amlodipine mean values of SBP/DBP were lower with 32/31 mmHg compared with baseline values (p<0.001. The treatment with amlodipine did not significantly affect the values of blood biochemical parameters of renal profile.

  9. Viral reproductive pathogens of dogs and cats.

    Science.gov (United States)

    Decaro, Nicola; Carmichael, Leland E; Buonavoglia, Canio

    2012-05-01

    This article reviews the current literature on the viral agents that cause reproductive failures in domestic carnivores (dogs and cats). A meaningful update is provided on the etiologic, clinical, pathologic, diagnostic, and prophylactic aspects of the viral infections impacting canine and feline reproduction as a consequence of either direct virus replication or severe debilitation of pregnant animals.

  10. Kipling's Cat: Learning from the New Student.

    Science.gov (United States)

    Pearce, Richard

    1996-01-01

    International schools can benefit from new students' fresh vision. Some students exhibit "culture shock" on arrival, while others, like Kipling's cat, act as though "all places are alike to them." This article examines the newcomer's adjustment process by proposing a model of personal identity development and poses questions to test the theory…

  11. Diagnostic radiology of the dog and cat

    International Nuclear Information System (INIS)

    Kealy, J.K.

    1981-01-01

    Radiolographic examinations have become an important aid in small animal veterinary practice. The emphasis of the examinations has shifted from surgical and orthopedic applications to internal diseases. The book gives a comprehensive picture of X-ray diagnosis in dogs and cats. (orig./MG) [de

  12. Schrödinger's Cat States

    Indian Academy of Sciences (India)

    Home; Journals; Resonance – Journal of Science Education; Volume 3; Issue 2. Schrödinger's Cat States. A N Maheshwari V P Srivastava. Research News Volume 3 Issue 2 February 1998 pp 79-82. Fulltext. Click here to view fulltext PDF. Permanent link: http://www.ias.ac.in/article/fulltext/reso/003/02/0079-0082 ...

  13. Surrenderers’ Relationships with Cats Admitted to Four Australian Animal Shelters

    Science.gov (United States)

    Zito, Sarah; Paterson, Mandy; Rand, Jacquie; Phillips, Clive J. C.

    2018-01-01

    Simple Summary The surrender of cats to animal shelters results in financial, social and moral burdens for the community. Human caretaking of cats was explored in a sample of people surrendering cats to shelters in Australia. At the shelters surrenderers classified themselves as owners or non-owners and a questionnaire identified that this was related to their method of acquisition of the cat, their association time with the cat, the closeness of their relationship with the cat and their degree of responsibility for the cat’s care. A model of ownership perception was developed to provide a better understanding of factors influencing ownership perception. Understanding ownership perceptions in cats surrendered to shelters is important as these can inform the development of more targeted and effective intervention strategies to reduce numbers of unwanted cats. Abstract The surrender of cats to animal shelters results in financial, social and moral burdens for the community. Correlations of caretaking and interactions with surrendered cats were calculated, to understand more about humans’ relationships with surrendered cats and the contribution of semi-owned cats to shelter intakes. A questionnaire was used to collect detailed information about 100 surrenderers’ relationships with cats they surrendered to four animal shelters in Australia, with each surrenderer classifying themselves as being either the owner or a non-owner of the surrendered cat (ownership perception). Method of acquisition of the cat, association time, closeness of the relationship with the cat and degree of responsibility for the cat’s care were all associated with ownership perception. Many non-owners (59%) fed and interacted with the cat they surrendered but rarely displayed other caretaking behaviours. However, most surrenderers of owned and unowned cats were attached to and felt responsible for the cat. Based on these results and other evidence, a causal model of ownership perception

  14. [Feeding of dogs and cats in Germany].

    Science.gov (United States)

    Becker, N; Dillitzer, N; Sauter-Louis, C; Kienzle, E

    2012-01-01

    The aim of this study was to determine epidemiological data on the feeding of dogs and cats in Germany. A total of 865 dog owners and 243 cat owners were interviewed using standardised questionnaires about their animals (age, sex, weight, body condition, health) and feeding, including treats, additional supplements and reasons for food changes, together with data on the pet owners (age, sex, education, profession). The interviews took place in the waiting rooms of veterinarians, in dog schools, animal shelters and public parks as well as via the internet. Body condition scoring (BCS, scale 1-9) was performed separately by the pet owners and the interviewer. The mean age of dogs was 4.8 years and of cats 6.8 years. The dogs' body weight ranged from 2.2kg (Pomeranian dog) to 95kg (Saint Bernard). The cats had a body weight from 2 to 11kg. Approximately 52% of dogs and cats were overweight (BCS6-9). Differences existed between the assessment by the owner and the interviewer. Many owners underestimated the body condition, in particular, moderate overweight was not recognised (BCS6-7). Commercial food was exclusively used by 58% of dog and 90% of cat owners, while 35% and 10%, respectively, combined these with additional feed. Nearly 8% of dog and 7 years) and sick dogs received home-made diets more often. Older pet owners (≥ 46 years) fed their pets home-made diets more frequently. The education and profession of owners did not affect the percentage of home-made diets. There was no effect of the type of diet on BCS. Owners with a lower education as well as housewives and pensioners more often had overweight pets. Older owners and working owners gave treats less frequently. However, 95% of dogs and 65% of cats received treats. Being overweight is the biggest dietary problem. In comparison to previous studies, the number of overweight pets has increased. Pet owners should be advised early on excess weight, because the onset of being overweight is often not recognised

  15. Metabolic response to three different diets in lean cats and cats predisposed to overweight

    OpenAIRE

    Keller, Claudia; Liesegang, Annette; Frey, Diana; Wichert, Brigitta

    2017-01-01

    Background The existence of a genetic predisposition to obesity is commonly recognized in humans and rodents. Recently, a link between genetics and overweight was shown in cats. The goal of this study was to identify the effect of diet composition on plasma levels of glucose, insulin, free fatty acids and triglycerides in cats receiving different diets (high-carbohydrate, high-fat and high-protein diets). Results Insulin and leptin concentrations were significantly correlated with phenotype. ...

  16. Estimation of Viable Biomass In Wastewater And Activated Sludge By Determination of ATP, Oxygen Utilization Rate And FDA Hydrolysis

    DEFF Research Database (Denmark)

    Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.

    1992-01-01

    ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...

  17. The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis.

    Science.gov (United States)

    Knoepfler, Paul S; Turner, Leigh G

    2018-01-01

    Hundreds of businesses in the US currently advertise a wide range of non-US FDA-approved stem cell interventions. Here we present a novel systematic temporal analysis of US companies engaged in direct-to-consumer marketing of putative stem cell treatments. Between 2009 and 2014, the number of new US stem cell businesses with websites grew rapidly, at least doubling on average every year. From 2014 to 2016, approximately 90-100 new stem cell business websites appeared per year. In contrast, from 2012 to the present, regulatory activity in the form of FDA warning letters has been limited. These data point to a problematic disconnect between a rapidly expanding US direct-to-consumer stem cell industry and limited FDA oversight of this marketplace. More consistent, timely and effective FDA actions are urgently needed.

  18. HEAD MOVEMENT DURING WALKING IN THE CAT

    Science.gov (United States)

    ZUBAIR, HUMZA N.; BELOOZEROVA, IRINA N.; SUN, HAI; MARLINSKI, VLADIMIR

    2016-01-01

    Knowledge of how the head moves during locomotion is essential for understanding how locomotion is controlled by sensory systems of the head. We have analyzed head movements of the cat walking along a straight flat pathway in the darkness and light. We found that cats' head left-right translations, and roll and yaw rotations oscillated once per stride, while fore-aft and vertical translations, and pitch rotations oscillated twice. The head reached its highest vertical positions during second half of each forelimb swing, following maxima of the shoulder/trunk by 20–90°. Nose-up rotation followed head upward translation by another 40–90° delay. The peak-to-peak amplitude of vertical translation was ~1.5 cm and amplitude of pitch rotation was ~3°. Amplitudes of lateral translation and roll rotation were ~1 cm and 1.5–3°, respectively. Overall, cats' heads were neutral in roll and 10–30° nose-down, maintaining horizontal semicircular canals and utriculi within 10° of the earth horizontal. The head longitudinal velocity was 0.5–1 m/s, maximal upward and downward linear velocities were ~0.05 and ~0.1 m/s, respectively, and maximal lateral velocity was ~0.05 m/s. Maximal velocities of head pitch rotation were 20–50 °/s. During walking in light, cats stood 0.3–0.5 cm taller and held their head 0.5–2 cm higher than in darkness. Forward acceleration was 25–100% higher and peak-to-peak amplitude of head pitch oscillations was ~20 °/s larger. We concluded that, during walking, the head of the cat is held actively. Reflexes appear to play only a partial role in determining head movement, and vision might further diminish their role. PMID:27339731

  19. Metabolic response to three different diets in lean cats and cats predisposed to overweight.

    Science.gov (United States)

    Keller, Claudia; Liesegang, Annette; Frey, Diana; Wichert, Brigitta

    2017-06-19

    The existence of a genetic predisposition to obesity is commonly recognized in humans and rodents. Recently, a link between genetics and overweight was shown in cats. The goal of this study was to identify the effect of diet composition on plasma levels of glucose, insulin, free fatty acids and triglycerides in cats receiving different diets (high-carbohydrate, high-fat and high-protein diets). Insulin and leptin concentrations were significantly correlated with phenotype. Insulin levels were lower, whereas leptin levels were higher in cats predisposed to overweight. The other blood parameters were not correlated with phenotype. Intake of the high-carbohydrate diet resulted in higher insulin concentrations compared with the two other diets. Insulin levels were within the values described for non-obese cats in previous studies. There was no difference in metabolic response between the two groups. As the high-carbohydrate diet led to the highest insulin blood concentrations, it might be useful to avoid such diets in cats predisposed to overweight. In addition, even cats with genetically linked obesity can regain insulin sensitivity after weight loss.

  20. An experimental study on cerebral paragonimiasis using cats

    International Nuclear Information System (INIS)

    Lee, Seon Kyu; Chang, Kee Hyun; Goo, Jin Mo; Han, Moon Hee; Shin, Yong Moon; Choo, Sung Wook; Yu, In Kyu; Cho, Seung Yull; Kong, Yoon

    1994-01-01

    It is important to diagnosis paragonimiasis in early active because it can be dared by chemotherapy. However, it is difficult to make a correct diagnosis of cerebral paragonimiasis in the early active stage, and the radiographic findings of cerebral paragonimiasis have been rarely reported. Thus, this experimental study was designed to produce early active cerebral paragonimiasis and to demonstrate radiologic-pathologic correlations. In 8 cats, 7-8 metacercariae of Paragonimus Westermani were directly introduced into brain parenchyma of each cat's after trephination of the skull. In another 16 cats, the juvenile worms and the adult worms that had developed for varying periods (2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks) in the lunges of another cats were introduced into the brain parenchyma of each cat's with the same procedure described above. Follow -up MR images and chest radiographs were obtained at 2 days, 1 weeks, 2 weeks, 4 weeks and 8 weeks after inoculation. The autopsies and histopathological examinations of the cat's brain were undertaken in 22 cats. In 9 cats that were suspected with pulmonary lesion on chest radiograph, the soft tissue radiographs of inflated-fixed lungs were obtained. In one cat with inoculation of adult worm, acute suppurative inflammation of the brain parenchyma was demonstrated. But the other cats with inoculation of adult worm or juvenile worm and the cats with intentional of metacercaris did not reveal any evidence of acute cerebral paragonimiasis. More than half of the introduce metacercariae (5 out of 8 cats) were found in the lung parenchyma, while only 25% (4 out of 16 cats) of the adult worm inoculated cats were. Acute suppurative inflammation suggesting acute stage cerebral paragonimiasis was obtained in one case of adult worm inoculated cat. Most of the inoculated metacercariae and some of the juvenile worms or adult worms were migrated to the lungs

  1. An experimental study on cerebral paragonimiasis using cats

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Seon Kyu; Chang, Kee Hyun; Goo, Jin Mo; Han, Moon Hee; Shin, Yong Moon; Choo, Sung Wook; Yu, In Kyu [Seoul National University College of Medicine, Seoul (Korea, Republic of); Cho, Seung Yull; Kong, Yoon [Chung-Ang University College of Medicine, Seoul (Korea, Republic of)

    1994-06-15

    It is important to diagnosis paragonimiasis in early active because it can be dared by chemotherapy. However, it is difficult to make a correct diagnosis of cerebral paragonimiasis in the early active stage, and the radiographic findings of cerebral paragonimiasis have been rarely reported. Thus, this experimental study was designed to produce early active cerebral paragonimiasis and to demonstrate radiologic-pathologic correlations. In 8 cats, 7-8 metacercariae of Paragonimus Westermani were directly introduced into brain parenchyma of each cat's after trephination of the skull. In another 16 cats, the juvenile worms and the adult worms that had developed for varying periods (2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks) in the lunges of another cats were introduced into the brain parenchyma of each cat's with the same procedure described above. Follow -up MR images and chest radiographs were obtained at 2 days, 1 weeks, 2 weeks, 4 weeks and 8 weeks after inoculation. The autopsies and histopathological examinations of the cat's brain were undertaken in 22 cats. In 9 cats that were suspected with pulmonary lesion on chest radiograph, the soft tissue radiographs of inflated-fixed lungs were obtained. In one cat with inoculation of adult worm, acute suppurative inflammation of the brain parenchyma was demonstrated. But the other cats with inoculation of adult worm or juvenile worm and the cats with intentional of metacercaris did not reveal any evidence of acute cerebral paragonimiasis. More than half of the introduce metacercariae (5 out of 8 cats) were found in the lung parenchyma, while only 25% (4 out of 16 cats) of the adult worm inoculated cats were. Acute suppurative inflammation suggesting acute stage cerebral paragonimiasis was obtained in one case of adult worm inoculated cat. Most of the inoculated metacercariae and some of the juvenile worms or adult worms were migrated to the lungs.

  2. An evaluation of the FDA's analysis of the costs and benefits of the graphic warning label regulation.

    Science.gov (United States)

    Chaloupka, Frank J; Warner, Kenneth E; Acemoğlu, Daron; Gruber, Jonathan; Laux, Fritz; Max, Wendy; Newhouse, Joseph; Schelling, Thomas; Sindelar, Jody

    2015-03-01

    The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Behavioral differences between urban feeding groups of neutered and sexually intact free-roaming cats following a trap-neuter-return procedure.

    Science.gov (United States)

    Finkler, Hilit; Gunther, Idit; Terkel, Joseph

    2011-05-01

    To examine behavioral differences during a 1-year observational period between urban feeding groups of neutered and sexually intact free-roaming cats following a trap-neuter-return procedure. Natural-setting trial. Animals-Free-roaming cats (n = 184) living in 4 feeding groups in an urban region of Israel. Trap-neuter-return procedures were applied to 2 cat feeding groups (A and B). Their social and feeding behaviors and frequency of appearance at feeding time were compared with those of 2 unneutered cat groups (C and D). Behavioral data were obtained from weekly observations before and during feeding over a 1-year period. Results-A lower rate of agonistic interactions was observed in the neutered groups than in the unneutered groups. Sexually intact male cats participated in more agonistic male-male encounters than did neutered male cats. Of 199 such encounters in the feeding groups, only 1 occurred between 2 neutered males. Neutered cats in group A appeared earlier and had higher frequencies of feeding and appearance at the feeding site, compared with unneutered cats. Less aggression was observed in the neutered groups, specifically, fewer agonistic neutered-neutered male encounters occurred. This reduced agonistic behavior of neutered males resulted in reduced fighting and vocalizations, potentially leading to fewer injuries and reduced transmission of fight-related infectious diseases and reduced noise disturbance from a human perspective. Regarding food delivery, the feeding groups were time-and-place dependent, exhibiting context-related social interactions. When competing for food resources, as neutered cats time their arrival in accordance with food delivery, they thereby gain access to the choicest items.

  4. The radiographic appearance of pulmonary histoplasmosis in the cat

    International Nuclear Information System (INIS)

    Wolf, A.M.; Green, R.W.

    1987-01-01

    A retrospective study of 18 cats with pulmonary histoplasmosis was conducted to evaluate radiographic patterns of disease and to determine age, breed, and sex distributions. All cats had active disease confirmed by biopsy/aspiration cytology (lung, bone marrow, peripheral lymph nodes, pleural fluid) or necropsy examination. Cats 3 years of age or less had the highest incidence of disease; females outnumbered males 2 to 1. Radiographically, most cats had an interstitial pattern which appeared as a fine, diffuse or linear pattern, or as a more distinct nodular pattern. An alveolar pattern was an uncommon radiographic finding. Tracheobronchial lymphadenopathy and calcified lymph nodes or pulmonary parenchymal lesions were not identified in these cats

  5. The behaviour and ecology of domestic cats (Felis catus L.)

    OpenAIRE

    Panaman, Roger

    1984-01-01

    This thesis is a reconnaissance of the behavioural ecology of domestic cats. The principal subjects were two groups of farm cats. There was also a group of captive cats and a house cat. The study differs from all previous ones in that the cats were tame and therefore could be shadowed and observed for long periods at all hours. It deals with (1) activity patterns and activity budget, (2) use of space and social behaviour, (3) scent communication, (4) foraging and (5) population dynamics.

  6. FDA drug safety communications: a narrative review and clinical considerations for older adults.

    Science.gov (United States)

    Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

    2012-08-01

    The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

  7. Has the tobacco industry evaded the FDA's ban on 'Light' cigarette descriptors?

    Science.gov (United States)

    Connolly, Gregory N; Alpert, Hillel R

    2014-03-01

    Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of "Lights" descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions. Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined. Manufacturers substituted "Gold" for "Light" and "Silver" for "Ultra-light" in the names of Marlboro sub-brands, and "Blue", "Gold", and "Silver" for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with "Lights" categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for "Lights" cigarettes remained unchanged. Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest.

  8. Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

    Science.gov (United States)

    Tippett, Elizabeth C; Chen, Brian K

    2015-12-01

    Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.

  9. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.

    Science.gov (United States)

    Davit, Barbara M; Kanfer, Isadore; Tsang, Yu Chung; Cardot, Jean-Michel

    2016-05-01

    The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for industry describing how to meet criteria for requesting a waiver of in vivo bioavailability and bioequivalence studies for highly soluble, highly permeable (BCS Class I) drugs. Subsequently, the World Health Organization (WHO) and European Medicines Agency (EMA) published guidelines recommending how to obtain BCS biowaivers for BCS Class III drugs (high solubility, low permeability), in addition to Class I drugs. In 2015, the US-FDA became better harmonized with the EMA and WHO following publication of two guidances for industry outlining criteria for obtaining BCS biowaivers for both Class I and Class III drugs. A detailed review and comparison of the BCS Class I and Class III criteria currently recommended by the US-FDA, EMA, and WHO revealed good convergence of the three agencies with respect to BCS biowaiver criteria. The comparison also suggested that, by applying the most conservative of the three jurisdictional approaches, it should be possible for a sponsor to design the same set of BCS biowaiver studies in preparing a submission for worldwide filing to satisfy US, European, and emerging market regulators. It is hoped that the availability of BCS Class I and Class III biowaivers in multiple jurisdictions will encourage more sponsors to request waivers of in vivo bioavailability/bioequivalence testing using the BCS approach.

  10. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models.

    Science.gov (United States)

    Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar

    2017-01-01

    Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that

  11. Mining FDA drug labels using an unsupervised learning technique - topic modeling

    Directory of Open Access Journals (Sweden)

    Xu Xiaowei

    2011-10-01

    Full Text Available Abstract Background The Food and Drug Administration (FDA approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P Conclusions The successful application of topic modeling on the FDA drug labeling demonstrates its potential utility as a hypothesis generation means to infer hidden relationships of concepts such as, in this study, drug safety and therapeutic use

  12. FDA gives final approval to Depo amid concerns over safety, cost and coercion.

    Science.gov (United States)

    1992-11-12

    In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than 30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is .5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not

  13. Sensitivity of fecal occult blood testing in the cat.

    Science.gov (United States)

    Rudinsky, Adam J; Guillaumin, Julien; Gilor, Chen

    2017-06-01

    Objectives The impact of dietary factors on fecal occult blood (FOB) testing has been previously evaluated in cats, but the analytical sensitivity of this point-of-care test remains unexamined. The primary goal of this study was to assess the analytical sensitivity of the FOB test in cats. Methods Five cats were used in a repeated measures study. Following oral administration of blood, feces were collected and tested every 12 h for FOB and melena. All cats were fed an animal protein-free diet starting the week before entry into the study. Blood was administered on a milligram of hemoglobin per kilogram of body weight basis, and dosed at 1.5, 3, 15, 30 and 45 mg/kg hemoglobin in series with a wash-out period between each trial. Results FOB was detected in one cat at 1.5 mg/kg hemoglobin, three cats at 3 mg/kg hemoglobin and in all five cats at 15, 30 and 45 mg/kg hemoglobin. Melena was noted in one cat at 30 mg/kg and four cats at 45 mg/kg, but not at lower doses. Conclusions and relevance Administration of 15 mg/kg hemoglobin (equivalent to about 1.5 ml blood) was sufficient for positive results in all cats. However, detection occurred with as little as 1.5 mg/kg hemoglobin. Thus, FOB has good analytical sensitivity in cats under appropriate clinical situations.

  14. Comparative serological investigation between cat and tiger blood for transfusion.

    Science.gov (United States)

    Thengchaisri, Naris; Sinthusingha, Chayakrit; Arthitwong, Surapong; Sattasathuchana, Panpicha

    2017-06-29

    Evidence suggests that non-domesticated felids inherited the same AB-erythrocyte antigens as domestic cats. To study the possible compatibility of tiger blood with that of other endangered felidae, blood samples from captive tigers and domestic cats were subjected to an in vitro study. The objectives of this study were to (1) identify whether the captive tigers had blood type AB and (2) determine the compatibility between the blood of captive tigers and that of domestic cats with a similar blood type. The anti-coagulated blood with ethylenediaminetetraacetic acid of 30 tigers was examined to determine blood type, and a crossmatching test was performed between tiger and cat blood. All 30 tigers had blood type A. Tube agglutination tests using tiger plasma with cat erythrocytes resulted in 100% agglutination (n=30) with type B cat erythrocytes and 76.7% agglutination (n=23) with type A cat erythrocytes. The 80% of major and 60% of minor compatibilities between blood from 10 tigers and 10 domestic cats with blood type A were found to pass compatibility tests. Interestingly, 3/10 of the tigers' red blood cell samples were fully compatible with all cat plasmas, and 1/10 of the tiger plasma samples were fully compatible with the type A red cells of domestic cats. Although the result of present findings revealed type-A blood group in the surveyed tigers, the reaction of tiger plasma with Type-A red cell from cats suggested a possibility of other blood type in tigers.

  15. Hepatic abscesses in cats: 14 cases (1985-2002).

    Science.gov (United States)

    Sergeeff, Jennifer S; Armstrong, P Jane; Bunch, Susan E

    2004-01-01

    In this retrospective study, we describe 14 cats diagnosed with hepatic abscesses. The objective of the study was to report the clinical signs, physical examination findings, clinicopathologic findings, and outcomes in affected cats. These findings were then compared with those previously reported in dogs and humans. Clinical signs were vague and included anorexia, lethargy, and weight loss. Only 23% of cats had fever, whereas 31% were hypothermic. Increases in serum activities of alanine aminotransferase and alkaline phosphatase were found in 45 and 18%, respectively, of the 11 cats that had laboratory work performed. Abdominal ultrasound examinations were performed in 7 cats, and abnormalities were found in 71% of them. Four cats had solitary abscesses, all of which were located in the right liver lobes. The other 10 cats had multifocal small abscesses or microabscesses, and all of these cats had clinical signs suggestive of sepsis. Cytologic evaluation of samples obtained by abdominocentesis indicated septic inflammation in 67% of cats in which peritoneal fluid was analyzed. Hepatic abscess cultures yielded polymicrobial growth in 66% of the cats: Escherichia coli was the most commonly cultured organism. Overall mortality rate was 79%. All survivors underwent exploratory laparotomy for partial hepatectomy to resect the abscess followed by medical management. Hepatic abscesses should be considered in cats with signs consistent with sepsis. More routine use of ultrasonography may aid in earlier diagnosis of hepatic abscesses, potentially improving prognosis and outcome.

  16. Vitamin D status in cats with feline immunodeficiency virus.

    Science.gov (United States)

    Titmarsh, Helen F; Lalor, Stephanie M; Tasker, Severine; Barker, Emily N; Berry, Jacqueline; Gunn-More, Danielle; Mellanby, Richard J

    2015-10-01

    Feline immunodeficiency virus (FIV) is a lentivirus that can lead to a syndrome of acquired immune dysfunction. Infected cats often remain asymptomatic for several years before immune dysfunction leads to an increased risk for the development of systemic diseases, neoplasia and opportunistic infections. FIV is structurally related to human immunodeficiency virus (HIV) and the pathogenesis of FIV-related disease is similar to that seen in HIV-infected patients. Observational studies have documented an association between low plasma vitamin D and HIV infection. Vitamin D status has been shown to be associated with HIV-related disease progression, morbidity and mortality. The objective of this study was to examine the hypothesis that vitamin D status, as assessed by serum 25-hydroxyvitamin D [25(OH)D] concentrations, are lower in cats with FIV infection compared to healthy control cats. Serum 25(OH)D concentrations were measured in 20 healthy cats, 39 hospitalized ill cats and 59 cats infected with FIV. Cats which were FIV infected had significantly lower 25(OH)D concentrations compared to healthy control cats. Serum 25(OH)D concentrations were not significantly different between FIV-infected cats and hospitalized ill cats. Further investigations are warranted to determine whether vitamin D status influences the prognosis of cats infected with FIV.

  17. Opinions from the front lines of cat colony management conflict.

    Science.gov (United States)

    Peterson, M Nils; Hartis, Brett; Rodriguez, Shari; Green, Matthew; Lepczyk, Christopher A

    2012-01-01

    Outdoor cats represent a global threat to terrestrial vertebrate conservation, but management has been rife with conflict due to differences in views of the problem and appropriate responses to it. To evaluate these differences we conducted a survey of opinions about outdoor cats and their management with two contrasting stakeholder groups, cat colony caretakers (CCCs) and bird conservation professionals (BCPs) across the United States. Group opinions were polarized, for both normative statements (CCCs supported treating feral cats as protected wildlife and using trap neuter and release [TNR] and BCPs supported treating feral cats as pests and using euthanasia) and empirical statements. Opinions also were related to gender, age, and education, with females and older respondents being less likely than their counterparts to support treating feral cats as pests, and females being less likely than males to support euthanasia. Most CCCs held false beliefs about the impacts of feral cats on wildlife and the impacts of TNR (e.g., 9% believed feral cats harmed bird populations, 70% believed TNR eliminates cat colonies, and 18% disagreed with the statement that feral cats filled the role of native predators). Only 6% of CCCs believed feral cats carried diseases. To the extent the beliefs held by CCCs are rooted in lack of knowledge and mistrust, rather than denial of directly observable phenomenon, the conservation community can manage these conflicts more productively by bringing CCCs into the process of defining data collection methods, defining study/management locations, and identifying common goals related to caring for animals.

  18. Hypoglycemia associated with refeeding syndrome in a cat.

    Science.gov (United States)

    DeAvilla, Marisa D; Leech, Elizabeth B

    2016-11-01

    To describe the clinical presentation and biochemical abnormalities occurring during the successful treatment of refeeding syndrome in a cat. A 2-year-old neutered male domestic shorthair cat presented after having been missing for 12 weeks. The cat had clinical signs of severe starvation. Common complications developed during refeeding (eg, hypophosphatemia, hypokalemia, and hemolytic anemia). The cat also developed hypoglycemia, a complication common in people but not previously reported in a cat. Hypoglycemia and electrolyte deficiencies were managed with intravenous supplementation. The cat was successfully treated and was discharged alive 7 days after presentation. Hypoglycemia has not been reported previously as a complication of refeeding in a cat. Frequent monitoring of electrolyte, mineral, and blood glucose concentrations is essential to successful management of refeeding syndrome. The ideal refeeding strategy is unknown at this time. Evidence suggests that a diet low in carbohydrate decreases the likelihood of metabolic derangements commonly associated with refeeding. © Veterinary Emergency and Critical Care Society 2016.

  19. Occupancy of the Invasive Feral Cat Varies with Habitat Complexity.

    Directory of Open Access Journals (Sweden)

    Rosemary Hohnen

    Full Text Available The domestic cat (Felis catus is an invasive exotic in many locations around the world and is thought to be a key factor driving recent mammal declines across northern Australia. Many mammal species native to this region now persist only in areas with high topographic complexity, provided by features such as gorges or escarpments. Do mammals persist in these habitats because cats occupy them less, or despite high cat occupancy? We show that occupancy of feral cats was lower in mammal-rich habitats of high topographic complexity. These results support the idea that predation pressure by feral cats is a factor contributing to the collapse of mammal communities across northern Australia. Managing impacts of feral cats is a global conservation challenge. Conservation actions such as choosing sites for small mammal reintroductions may be more successful if variation in cat occupancy with landscape features is taken into account.

  20. MRI of secondary cervical syringomyelia in four cats

    International Nuclear Information System (INIS)

    Okada, Midori; Itou, Takuya; Sakai, Takeo; Kitagawa, Masato; Ito, Daisuke; Kanayama, Kiichi

    2009-01-01

    This report describes the use of magnetic resonance imaging (MRI) to diagnose cervical syringomyelia in 4 cats. MRI revealed enlargement of the lateral ventricle in all the cats. Of the 4 cases, MRI revealed herniation of the cerebellum in 3 cats, an isolated fourth ventricle in 1 cat, severe hydrocephalus in 2 cats and brain masses in 1 cat. In this report, the cervical syringomyelia in these cats may have been due to formation of a secondary syrinx (enlargement of the central canal) as a result of blockage of flow in the outlet of the fourth ventricle caused by feline infectious peritonitis (FIP) encephalomyelitis or secondary cerebellar tonsillar herniation caused by increased intracranial pressure due to intracranial masses or may have been due to caudal compression of the cerebellum caused by increased intracranial pressure due to hydrocephalus. (author)

  1. Consortium on Methods Evaluating Tobacco: Research Tools to Inform FDA Regulation of Snus.

    Science.gov (United States)

    Berman, Micah L; Bickel, Warren K; Harris, Andrew C; LeSage, Mark G; O'Connor, Richard J; Stepanov, Irina; Shields, Peter G; Hatsukami, Dorothy K

    2017-10-04

    The U.S. Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this paper is to describe these assessment methods using a U.S. manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This paper integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, and consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. © The Author 2017. Published by Oxford University Press

  2. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    Science.gov (United States)

    1995-01-06

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.

  3. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Science.gov (United States)

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  4. Thyroid Cysts in Cats: A Retrospective Study of 40 Cases.

    Science.gov (United States)

    Miller, M L; Peterson, M E; Randolph, J F; Broome, M R; Norsworthy, G D; Rishniw, M

    2017-05-01

    Thyroid cysts are rare in cats and poorly documented. To report distinguishing clinical features and treatment responses of cats with thyroid cysts. Forty client-owned cats. Retrospective review of medical records for cats with thyroid cysts confirmed by scintigraphy, ultrasound, magnetic resonance imaging, or necropsy at 4 referral centers between 2005 and 2016. Signalment, clinical findings, diagnostic testing, treatment, and outcome were recorded. Cats ranged in age from 8 to 20 years with no apparent breed or sex predilection. 37 of 40 (93%) cats were hyperthyroid (duration, 1-96 months). Clinical findings included palpable neck mass (40/40, 100%), weight loss (15/40, 38%), dysphagia (8/40, 20%), decreased appetite (5/40, 13%), and dyspnea (4/40, 10%). Cysts were classified as small (≤8 cm 3 ) in 16 (40%) and large (>8 cm 3 ) in 24 (60%) cats. Of 25 cats treated with radioiodine, hyperthyroidism resolved in 23 (92%), whereas thyroid cysts resolved in 12 (50%). Radioiodine treatment resolved small cysts in 8 of 13 (62%) cats and large cysts in 4 of 11 (36%) cats. Eight cats, including 2 euthyroid cats, underwent thyroid-cystectomy; 3 with bilateral thyroid involvement were euthanized postoperatively for hypocalcemia. Excised cystic thyroid masses were identified as cystadenoma (4) and carcinoma (4). Thyroid cysts are encountered in hyperthyroid and euthyroid cats with benign and malignant thyroid tumors. Radioiodine treatment alone inconsistently resolved thyroid cysts. Thyroid-cystectomy could be considered in cats with unilateral thyroid disease or when symptomatic cysts persist despite successful radioiodine treatment of hyperthyroidism. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  5. Intensive intravenous infusion of insulin in diabetic cats.

    Science.gov (United States)

    Hafner, M; Dietiker-Moretti, S; Kaufmann, K; Mueller, C; Lutz, T A; Reusch, C E; Zini, E

    2014-01-01

    Remission occurs in 10-50% of cats with diabetes mellitus (DM). It is assumed that intensive treatment improves β-cell function and increases remission rates. Initial intravenous infusion of insulin that achieves tight glycemic control decreases subsequent insulin requirements and increases remission rate in diabetic cats. Thirty cats with newly diagnosed DM. Prospective study. Cats were randomly assigned to one of 2 groups. Cats in group 1 (n = 15) received intravenous infusion of insulin with the goal of maintaining blood glucose concentrations at 90-180 mg/dL, for 6 days. Cats in group 2 (n = 15) received subcutaneous injections of insulin glargine (cats ≤4 kg: 0.5-1.0 IU, q12h; >4 kg 1.5-2.0 IU, q12h), for 6 days. Thereafter, all cats were treated with subcutaneous injections of insulin glargine and followed up for 6 months. Cats were considered in remission when euglycemia occurred for ≥4 weeks without the administration of insulin. Nonparametric tests were used for statistical analysis. In groups 1 and 2, remission was achieved in 10/15 and in 7/14 cats (P = .46), and good metabolic control was achieved in 3/5 and in 1/7 cats (P = .22), respectively. Overall, good metabolic control or remission occurred in 13/15 cats of group 1 and in 8/14 cats of group 2. In group 1, the median insulin dosage given during the 6-month follow-up was significantly lower than in group 2 (group 1: 0.32 IU/kg/day, group 2: 0.51 IU/kg/day; P = .013). Initial intravenous infusion of insulin for tight glycemic control in cats with DM decreases insulin requirements during the subsequent 6 months. Copyright © 2014 by the American College of Veterinary Internal Medicine.

  6. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  7. Drought controls on H2O2 accumulation, catalase (CAT) activity and CAT gene expression in wheat.

    Science.gov (United States)

    Luna, Celina M; Pastori, Gabriela M; Driscoll, Simon; Groten, Karin; Bernard, Stephanie; Foyer, Christine H

    2005-01-01

    Plants co-ordinate information derived from many diverse external and internal signals to ensure appropriate control of gene expression under optimal and stress conditions. In this work, the relationships between catalase (CAT) and H2O2 during drought in wheat (Triticum aestivum L.) are studied. Drought-induced H2O2 accumulation correlated with decreases in soil water content and CO2 assimilation. Leaf H2O2 content increased even though total CAT activity doubled under severe drought conditions. Diurnal regulation of CAT1 and CAT2 mRNA abundance was apparent in all conditions and day/night CAT1 and CAT2 expression patterns were modified by mild and severe drought. The abundance of CAT1 transcripts was regulated by circadian controls that persisted in continuous darkness, while CAT2 was modulated by light. Drought decreased abundance, and modified the pattern, of CAT1 and CAT2 mRNAs. It was concluded that the complex regulation of CAT mRNA, particularly at the level of translation, allows precise control of leaf H2O2 accumulation.

  8. 1993 CAT workshop on beamline optical designs

    International Nuclear Information System (INIS)

    1993-11-01

    An Advanced Photon Source (APS) Collaborative Access Team (CAT) Workshop on Beamline Optical Designs was held at Argonne National Laboratory on July 26--27, 1993. The goal of this workshop was to bring together experts from various synchrotron sources to provide status reports on crystal, reflecting, and polarizing optics as a baseline for discussions of issues facing optical designers for CAT beamlines at the APS. Speakers from the European Synchrotron Radiation Facility (ESRF), the University of Chicago, the National Synchrotron Light Source, and the University of Manchester (England) described single- and double-crystal monochromators, mirrors, glass capillaries, and polarizing optics. Following these presentations, the 90 participants divided into three working groups: Crystal Optics Design, Reflecting Optics, and Optics for Polarization Studies. This volume contains copies of the presentation materials from all speakers, summaries of the three working groups, and a ''catalog'' of various monochromator designs

  9. CT studies of brain abscesses in cats

    International Nuclear Information System (INIS)

    Kretzschmar, K.; Wallenfang, T.; Bohl, J.

    1981-01-01

    Cerebral abscesses were produced in 56 cats by introducing staphylococcus aureus into the white matter of one cerebral hemisphere, using a stereotaxic apparatus. The cats were treated with antibiotics and/or steroids. The size and density of the inflammatory process and the abscess ring were measured on postcontrast CT scans. Differences were found depending on the stage of the abscess, but the deviation of values was too great for determining the age of the abscess from one measurement, to be able to apply proper treatment. The size and density of the abscesses were the same on CT whether the animals were treated or not. This was contrary to the clinical picture, the measurements of edema, and the histopathological studies. (orig.)

  10. OCULAR SONOGRAM OF INDONESIAN STRAY CAT EYES

    Directory of Open Access Journals (Sweden)

    Mokhamad Fakhrul Ulum

    2017-08-01

    Full Text Available The purpose of this study was to investigate Indonesian stray cat (KLI eyes by transpalpebrae B-mode ultrasound imaging. Eight healthy adult stray cats with 3.0-4.0 kg body weight were underwent of eyes ultrasound scanning without anesthesia or sedation. Linear ultrasound transducer with 7.5-15 MHz of frequency and ultrasound-gel were adhered directly to palpebral on the closed eyes. The results showed that the internal architecture of eyes was visible in different echogenicity according to the constituent of eyes structure. The sonograms with hypoechoic to hyperechoic parts of eyes were cornea, iris, cilliary body, suspensor ligament, sclera, and lens capsule. Moreover, anechoic parts of sonograms that having aqueous constituent were anterior chamber, posterior chamber, and vitreous humor. Based on the result, it can be concluded that B-mode ultrasound was able to assess the eyes through transpalpebral scanning.

  11. 1993 CAT workshop on beamline optical designs

    Energy Technology Data Exchange (ETDEWEB)

    1993-11-01

    An Advanced Photon Source (APS) Collaborative Access Team (CAT) Workshop on Beamline Optical Designs was held at Argonne National Laboratory on July 26--27, 1993. The goal of this workshop was to bring together experts from various synchrotron sources to provide status reports on crystal, reflecting, and polarizing optics as a baseline for discussions of issues facing optical designers for CAT beamlines at the APS. Speakers from the European Synchrotron Radiation Facility (ESRF), the University of Chicago, the National Synchrotron Light Source, and the University of Manchester (England) described single- and double-crystal monochromators, mirrors, glass capillaries, and polarizing optics. Following these presentations, the 90 participants divided into three working groups: Crystal Optics Design, Reflecting Optics, and Optics for Polarization Studies. This volume contains copies of the presentation materials from all speakers, summaries of the three working groups, and a ``catalog`` of various monochromator designs.

  12. Allium species poisoning in dogs and cats

    Directory of Open Access Journals (Sweden)

    BS Salgado

    2011-01-01

    Full Text Available Dogs and cats are the animals that owners most frequently seek assistance for potential poisonings, and these species are frequently involved with toxicoses due to ingestion of poisonous food. Feeding human foodstuff to pets may prove itself dangerous for their health, similarly to what is observed in Allium species toxicosis. Allium species toxicosis is reported worldwide in several animal species, and the toxic principles present in them causes the transformation of hemoglobin into methemoglobin, consequently resulting in hemolytic anemia with Heinz body formation. The aim of this review is to analyze the clinicopathologic aspects and therapeutic approach of this serious toxicosis of dogs and cats in order to give knowledge to veterinarians about Allium species toxicosis, and subsequently allow them to correctly diagnose this disease when facing it; and to educate pet owners to not feed their animals with Allium-containg food in order to better control this particular life-threatening toxicosis.

  13. Cheshire cat phenomena and quarks in nuclei

    International Nuclear Information System (INIS)

    Rho, M.

    1986-11-01

    The notion of the ''Cheshire Cat'' principle in hadron structure is developed rigorously in (1+1) dimensions and approximately in (3+1) dimensions for up- and down-quark flavor systems. This phenomenon is invoked to address the issue as to whether or not direct quark-gluon signatures can be ''seen'' in low-energy nuclear phenomena. How addition of the third flavor -strangeness- can modify the Cheshire Cat property is discussed. It is proposed that one of the primary objectives of nuclear physics be to probe -and disturb- the ''vacuum'' of the strong interactions (QCD) and that for this purpose the chiral symmetry SU(3)xSU(3) can play a crucial role in normal and extreme conditions. As an illustration, kaon condensation at a density ρ>∼ 3ρ 0 is discussed in terms of a toy model and is related to ''cleansing'' of the quark condensates from the vacuum

  14. Smokers' reactions to FDA regulation of tobacco products: findings from the 2009 ITC United States survey.

    Science.gov (United States)

    Fix, Brian V; O'Connor, Richard J; Fong, Geoffrey T; Borland, Ron; Cummings, K M; Hyland, Andrew

    2011-12-16

    On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC) United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

  15. Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey

    Directory of Open Access Journals (Sweden)

    Fix Brian V

    2011-12-01

    Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

  16. Safety assessment of FDA-approved (orlistat and lorcaserin) anti-obesity medications.

    Science.gov (United States)

    Halpern, Bruno; Halpern, Alfredo

    2015-02-01

    Options for treating obesity remain limited despite it being a chronic, recurrent and morbid condition. New drugs that are proposed for its treatment encounter strong reluctance by regulatory agencies and many doctors. This review will focus on the safety of an older drug, orlistat (the only one still approved in the European Union) and a newer recently FDA-approved one, lorcaserin. Both are approved as long-term monotherapy for obesity in the United States of America and they have demonstrated median weight loss of nearly 3% over placebo. Research, development and approval of new anti-obesity drugs are necessary for improved management of this chronic condition. Orlistat and lorcaserin are two FDA-approved drugs with limited overall efficacy. Nevertheless they are useful weapons for at least some obese individuals. Orlistat has a long and solid safety profile, whereas the safety of lorcaserin is still a matter of debate, mainly due to a lack of long-term data. However, lorcaserin's selective agonism on 5HT2c serotonin receptors diminishes concerns about valvulopathy associated with other serotonin agonists, such as fenfluramine.

  17. Larval zebrafish model for FDA-approved drug repositioning for tobacco dependence treatment.

    Directory of Open Access Journals (Sweden)

    Margot A Cousin

    Full Text Available Cigarette smoking remains the most preventable cause of death and excess health care costs in the United States, and is a leading cause of death among alcoholics. Long-term tobacco abstinence rates are low, and pharmacotherapeutic options are limited. Repositioning medications approved by the U.S. Food and Drug Administration (FDA may efficiently provide clinicians with new treatment options. We developed a drug-repositioning paradigm using larval zebrafish locomotion and established predictive clinical validity using FDA-approved smoking cessation therapeutics. We evaluated 39 physician-vetted medications for nicotine-induced locomotor activation blockade. We further evaluated candidate medications for altered ethanol response, as well as in combination with varenicline for nicotine-response attenuation. Six medications specifically inhibited the nicotine response. Among this set, apomorphine and topiramate blocked both nicotine and ethanol responses. Both positively interact with varenicline in the Bliss Independence test, indicating potential synergistic interactions suggesting these are candidates for translation into Phase II clinical trials for smoking cessation.

  18. FDA, CE mark or something else?-Thinking fast and slow.

    Science.gov (United States)

    Mishra, Sundeep

    There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  19. FDA, CE mark or something else?—Thinking fast and slow

    Directory of Open Access Journals (Sweden)

    Sundeep Mishra

    2017-01-01

    Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.

  20. In Vitro Tolerance of Drug-Naive Staphylococcus aureus Strain FDA209P to Vancomycin

    Science.gov (United States)

    Singh, Madhuri; Sasaki, Takashi; Morimoto, Yuh; Hishinuma, Tomomi; Hiramatsu, Keiichi

    2016-01-01

    ABSTRACT The mechanisms underlying bacterial tolerance to antibiotics are unclear. A possible adaptation strategy was explored by exposure of drug-naive methicillin-susceptible Staphylococcus aureus strain FDA209P to vancomycin in vitro. Strains surviving vancomycin treatment (vancomycin survivor strains), which appeared after 96 h of exposure, were slow-growing derivatives of the parent strain. Although the vancomycin MICs for the survivor strains were within the susceptible range, the cytokilling effects of vancomycin at 20-fold the MIC were significantly lower for the survivor strains than for the parent strain. Whole-genome sequencing demonstrated that ileS, encoding isoleucyl-tRNA synthetase (IleRS), was mutated in two of the three vancomycin survivor strains. The IleRS Y723H mutation is located close to the isoleucyl-tRNA contact site and potentially affects the affinity of IleRS binding to isoleucyl-tRNA, thereby inhibiting protein synthesis and leading to vancomycin tolerance. Introduction of the mutation encoding IleRS Y723H into FDA209P by allelic replacement successfully transferred the vancomycin tolerance phenotype. We have identified mutation of ileS to be one of the bona fide genetic events leading to the acquisition of vancomycin tolerance in S. aureus, potentially acting via inhibition of the function of IleRS. PMID:27855063

  1. Modeling and simulation in dose determination for biodefense products approved under the FDA animal rule.

    Science.gov (United States)

    Bergman, Kimberly L; Krudys, K; Seo, S K; Florian, J

    2017-04-01

    Development of effective medical countermeasures for biodefense is vital to United States biopreparedness and response in the age of terrorism, both foreign and domestic. A traditional drug development pathway toward approval is not possible for most biodefense-related indications, creating the need for alternative development pathways such as the FDA's Animal Rule. Under this unique regulatory mechanism, FDA-approval is based on adequate and well-controlled animal studies when it is neither ethical nor feasible to conduct human efficacy studies. Translation of animal efficacy findings to humans is accomplished by use of modeling and simulation techniques. Pharmacokinetic and exposure-response modeling allow effective dosing regimens in humans to be identified, which are expected to produce similar benefit to that observed in animal models of disease. In this review, the role of modeling and simulation in determining the human dose for biodefense products developed under the Food and Drug Administration's Animal Rule regulatory pathway is discussed, and case studies illustrating the utility of modeling and simulation in this area of development are presented.

  2. Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

    Science.gov (United States)

    Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

    2017-08-01

    We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

  3. A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications

    Science.gov (United States)

    Rogstad, Sarah; Faustino, Anneliese; Ruth, Ashley; Keire, David; Boyne, Michael; Park, Jun

    2017-05-01

    The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization. To further examine how MS is being used in successful BLAs, the applications were filtered based on the type and number of quality attributes characterized, the mass spectrometric workflows used (peptide mapping, intact mass analysis, and cleaved glycan analysis), the methods used to introduce the proteins into the gas phase (ESI, MALDI, or LC-ESI), and the specific types of instrumentation used. Analyses were conducted over a time course based on the FDA BLA approval to determine if any trends in utilization could be observed over time. Additionally, the different classes of protein-based biotherapeutics among the approved BLAs were clustered to determine if any trends could be attributed to the specific type of biotherapeutic.

  4. Data mining of the public version of the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Sakaeda, Toshiyuki; Tamon, Akiko; Kadoyama, Kaori; Okuno, Yasushi

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

  5. The contribution of cat owners' attitudes and behaviours to the free-roaming cat overpopulation in Tel Aviv, Israel.

    Science.gov (United States)

    Finkler, Hilit; Terkel, Joseph

    2012-04-01

    The attitudes and behaviours of cat owners in regard to treatment of cats may have a cumulative effect on the food availability, reproduction, density and welfare of the free-roaming cat population and thus also on the extent of cat overpopulation. Understanding this is thus a vital step in the a priori planning of cat management programs on any scale, as well as in developing public education programs on this issue. Although recent years have seen an accumulation of knowledge in regard to cat owners' attitudes and behaviours, the findings vary among countries and locations and in Israel this has never been investigated systematically. Using a questionnaire provided to cat owners in veterinary clinics, this study aimed at identifying those attitudes and behaviours that may be contributing to cat overpopulation in Tel Aviv, Israel, and at exploring the socio-economic factors that influence this problem. The findings show that the influential factors can be predicted from the cat owners' socio-economic status, mainly education and income, as well as gender and age. A consistency in those cat owner behaviours that contribute to cat overpopulation was also uncovered, revealing a sub-population of individuals who persist in the undesirable behaviours. Finally, a strong relationship between attitude and consequent behaviour was demonstrated, indicating the importance of education and targeted publicity as a means to influence attitudes and thereby change behaviours in this respect. We propose several measures by which to reduce the current extent of cat owners' contribution to the cat overpopulation: discouraging unwanted owner behaviours such as abandonment of their cats and allowing them to breed; promoting awareness of the neutering option among cat caretakers; and increasing pre-adoption neutering rates in shelters. Regional and national laws promoting responsible pet ownership need to be enacted. By improving the current level of knowledge and awareness among cat

  6. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy.

    Science.gov (United States)

    Pinkerton, JoAnn V; Pickar, James H

    2016-02-01

    We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk.

  7. High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

    KAUST Repository

    Zhang, Chen

    2012-02-01

    We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

  8. Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

    Directory of Open Access Journals (Sweden)

    Gilhyang Kim

    2016-11-01

    Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.

  9. Diagnosis of pancreatitis in dogs and cats.

    Science.gov (United States)

    Xenoulis, P G

    2015-01-01

    Pancreatitis is the most common disorder of the exocrine pancreas in both dogs and cats. Ante-mortem diagnosis of canine and feline pancreatitis can be challenging. The clinical picture of dogs and cats with pancreatitis varies greatly (from very mild to severe or even fatal) and is characterised by non-specific findings. Complete blood count, serum biochemistry profile and urinalysis should always be performed in dogs and cats suspected of having pancreatitis, although findings are not-specific for pancreatitis. Serum amylase and lipase activities and trypsin-like immunoreactivity (TLI) concentrations have no or only limited clinical value for the diagnosis of pancreatitis in either dogs or cats. Conversely, serum pancreatic lipase immunoreactivity (PLI) concentration is currently considered to be the clinicopathological test of choice for the diagnosis of canine and feline pancreatitis. Abdominal radiography is a useful diagnostic tool for the exclusion of other diseases that may cause similar clinical signs to those of pancreatitis. Abdominal ultrasonography can be very useful for the diagnosis of pancreatitis, but this depends largely on the clinician's experience. Histopathological examination of the pancreas is considered the gold standard for the diagnosis and classification of pancreatitis, but it is not without limitations. In clinical practice, a combination of careful evaluation of the animal's history, serum PLI concentration and abdominal ultrasonography, together with pancreatic cytology or histopathology when indicated or possible, is considered to be the most practical and reliable means for an accurate diagnosis or exclusion of pancreatitis compared with other diagnostic modalities. © 2015 British Small Animal Veterinary Association.

  10. Fatal disseminated toxoplasmosis in an immunocompetent cat

    Directory of Open Access Journals (Sweden)

    Susanna S. Nagel

    2013-02-01

    Full Text Available A 10-year-old domestic short hair cat was referred for investigation of anorexia and polydipsia of 3 days’ duration. Clinically the cat was obese, pyrexic (39.8 °C, had acute abdominal pain and severe bilirubinuria. Haematology and serum biochemistry revealed severe panleukopenia, thrombocytopenia, markedly elevated alanine aminotransferase (ALT and five-fold increased pre-prandial bile acids. Ultrasonographic evaluation of the abdomen did not identify any abnormalities. Serum tests for feline immunodeficiency virus (FIV and feline leukaemia virus (FeLV were negative. Broad-spectrum antibiotic treatment for infectious hepatitis was to no avail; the cat deteriorated and died 72 h after admission. Necropsy revealed mild icterus and anaemia, severe multifocal hepatic necrosis, serofibrinous hydrothorax, pulmonary oedema and interstitial pneumonia. Histopathology confirmed the macroscopic findings and revealed multifocal microgranulomata in the brain and myocardium, as well as areas of necrosis in lymph nodes and multifocally in splenic red pulp. Long bone shaft marrow was hyperplastic with a predominance of leukocyte precursors and megakaryocytes and splenic red pulp showed mild extramedullary haemopoiesis. Immunohistochemical staining for Toxoplasma gondii was strongly positive, with scattered cysts and tachyzoites in the liver, lymph nodes, spleen, lungs, brain, salivary glands and intracellularly in round cells in occasional blood vessels. Immunohistochemical staining for corona virus on the same tissues was negative, ruling out feline infectious peritonitis (FIP. Polymerase chain reaction (PCR on formalin-fixed paraffin-wax embedded tissues was positive for Toxoplasma sp., but attempts at sequencing were unsuccessful. This was the first case report of fulminant disseminated toxoplasmosis in South Africa, in which detailed histopathology in an apparently immunocompetent cat was described.

  11. Mycobacterial panniculitis caused by in a cat

    Directory of Open Access Journals (Sweden)

    Polina Vishkautsan

    2016-10-01

    Full Text Available Case summary A domestic shorthair cat was evaluated for chronic, bilateral, ulcerative dermatitis affecting the inguinal region and lateral aspects of both pelvic limbs. Histopathologic examination of skin biopsies collected throughout the course of disease revealed chronic pyogranulomatous ulcerative dermatitis. Aerobic bacterial skin cultures yielded growth of a methicillin-resistant Staphylococcus aureus and Corynebacterium amycolatum . Upon referral the clinical findings were suggestive of a non-tuberculous Mycobacterium species infection. Previously obtained skin cultures failed to yield growth of mycobacterial organisms. A deep skin biopsy was collected and submitted for mycobacterial culture. At 5 weeks of incubation Mycobacterium thermoresistibile was isolated. In previous reports, M thermoresistibile has been isolated after 2–4 days of incubation, suggesting that this strain may have been a slower growing variant, or other factors (such as prior antimicrobial therapy inhibited rapid growth of this isolate. The cat was hospitalized for intravenous antibiotic therapy, surgical debridement of wounds, vacuum-assisted wound closure therapy and reconstruction procedures. The wounds were ultimately primarily closed and the cat was discharged to the owner after 50 days of hospitalization. Seven months after hospitalization, the ulcerative skin lesions had healed. Relevance and novel information To our knowledge, only two cases of M thermoresistibile panniculitis have been reported in cats. In the only detailed report of feline M thermoresistibile panniculitis, treatment was not attempted. The second case only reported detection of M thermoresistibile by PCR without a clinical description of the case. In our case report, severe chronic skin infection with M thermoresistibile was addressed using prolonged specific antibiotic therapy, surgical debridement and reconstructions, and treatment of secondary bacterial infections.

  12. Cefazolin pharmacokinetics in cats under surgical conditions.

    Science.gov (United States)

    Albarellos, Gabriela A; Montoya, Laura; Passini, Sabrina M; Lupi, Martín P; Lorenzini, Paula M; Landoni, María F

    2017-10-01

    Objectives The aim of this study was to determine the plasma pharmacokinetic profile, tissue concentrations and urine elimination of cefazolin in cats under surgical conditions after a single intravenous dose of 20 mg/kg. Methods Intravenous cefazolin (20 mg/kg) was administered to nine young mixed-breed cats 30 mins before they underwent surgical procedures (ovariectomy or orchiectomy). After antibiotic administration, samples from blood, some tissues and urine were taken. Cefazolin concentrations were determined in all biological matrices and pharmacokinetic parameters were estimated. Results Initial plasma concentrations were high (C p(0) , 134.80 ± 40.54 µg/ml), with fast and moderately wide distribution (distribution half-life [t ½(d) ] 0.16 ± 0.15 h; volume of distribution at steady state [V (d[ss]) ] 0.29 ± 0.10 l/kg) and rapid elimination (body clearance [Cl B ], 0.21 ± 0.06 l/h/kg; elimination half-life [t ½ ], 1.18 ± 0.27 h; mean residence time 1.42 ± 0.36 h). Thirty to 60 mins after intravenous administration, cefazolin tissue concentrations ranged from 9.24 µg/ml (subcutaneous tissue) to 26.44 µg/ml (ovary). The tissue/plasma concentration ratio ranged from 0.18 (muscle) to 0.58 (ovary). Cefazolin urine concentrations were high with 84.2% of the administered dose being eliminated in the first 6 h postadministration. Conclusions and relevance Cefazolin plasma concentrations remained above a minimum inhibitory concentration of ⩽2 µg/ml up to 4 h in all the studied cats. This suggests that a single intravenous dose of 20 mg/kg cefazolin would be adequate for perioperative prophylactic use in cats.

  13. Endocrine emergencies in dogs and cats.

    Science.gov (United States)

    Koenig, Amie

    2013-07-01

    Success in treatment of endocrine emergencies is contingent on early recognition and treatment. Many endocrine diseases presenting emergently have nonspecific signs and symptoms. In addition, these endocrine crises are often precipitated by concurrent disease, further making early identification difficult. This article concentrates on recognition and emergency management of the most common endocrine crises in dogs and cats. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Earliest “Domestic” Cats in China Identified as Leopard Cat (Prionailurus bengalensis)

    Science.gov (United States)

    Vigne, Jean-Denis; Evin, Allowen; Cucchi, Thomas; Dai, Lingling; Yu, Chong; Hu, Songmei; Soulages, Nicolas; Wang, Weilin; Sun, Zhouyong; Gao, Jiangtao; Dobney, Keith; Yuan, Jing

    2016-01-01

    The ancestor of all modern domestic cats is the wildcat, Felis silvestris lybica, with archaeological evidence indicating it was domesticated as early as 10,000 years ago in South-West Asia. A recent study, however, claims that cat domestication also occurred in China some 5,000 years ago and involved the same wildcat ancestor (F. silvestris). The application of geometric morphometric analyses to ancient small felid bones from China dating between 5,500 to 4,900 BP, instead reveal these and other remains to be that of the leopard cat (Prionailurus bengalensis). These data clearly indicate that the origins of a human-cat ‘domestic’ relationship in Neolithic China began independently from South-West Asia and involved a different wild felid species altogether. The leopard cat’s ‘domestic’ status, however, appears to have been short-lived—its apparent subsequent replacement shown by the fact that today all domestic cats in China are genetically related to F. silvestris. PMID:26799955

  15. Continuous glucose monitoring in dogs and cats.

    Science.gov (United States)

    Wiedmeyer, C E; DeClue, A E

    2008-01-01

    Use of continuous glucose monitoring in veterinary medicine is gaining popularity. Through use of a commercially available continuous glucose monitor system, insights into daily glucose changes in dogs and cats are achievable. The continuous glucose monitoring system measures glucose concentrations in the interstitial fluid of the subcutaneous space by use of a small, flexible probe. When placed in the subcutaneous tissue, the probe is connected to a recording device that is attached to the animal and records the interstitial fluid glucose concentration every 5 minutes (288 readings per 24 hours). Once attached and properly calibrated, the instrument can remain in place for several days, hospitalization of the patient is not necessary, and the normal daily routine of the animal can be maintained. The data from the recording device are then downloaded and a very detailed picture of the interstitial fluid glucose concentration over that time period can be obtained. Subcutaneous interstitial fluid glucose concentrations have a good correlation to blood glucose concentrations within a defined range. The continuous glucose monitoring system has distinct advantages over traditional blood glucose curves and is a valuable tool for managing diabetic dogs and cats. In addition, other clinical uses for continuous glucose monitoring are being developed. This review is designed to outline the technology behind the continuous glucose monitoring system, describe the clinical use of the instrument, provide clinical examples in which it may be useful, and discuss future directions for continuous glucose monitoring in dogs and cats.

  16. Is Schrödinger's Cat Alive?

    Directory of Open Access Journals (Sweden)

    Mani L. Bhaumik

    2017-12-01

    Full Text Available Erwin Schrödinger is famous for presenting his wave equation of motion that jump-started quantum mechanics. His disenchantment with the Copenhagen interpretation of quantum mechanics led him to unveil the Schrödinger's cat paradox, which did not get much attention for nearly half a century. In the meantime, disappointment with quantum mechanics turned his interest to biology facilitating, albeit in a peripheral way, the revelation of the structure of DNA. Interest in Schrödinger's cat has recently come roaring back making its appearance conspicuously in numerous scientific articles. From the arguments presented here, it would appear that the legendary Schrödinger's cat is here to stay, symbolizing a profound truth that quantum reality exists at all scales; but we do not observe it in our daily macroscopic world as it is masked for all practical purposes, most likely by environmental decoherence with irreversible thermal effects. Quanta 2017; 6: 70–80.

  17. Insulin detemir treatment in diabetic cats in a practice setting.

    Science.gov (United States)

    Hoelmkjaer, Kirsten Madsen; Spodsberg, Eva-Maria Hohneck; Bjornvad, Charlotte Reinhard

    2015-02-01

    Insulin detemir is a long-acting insulin analogue and may represent a valuable treatment option for diabetic cats. So far, only one study addressing detemir treatment of diabetic cats has been published, and this was based on an intensive blood glucose monitoring protocol. The aim of the current, retrospective study was to evaluate the effect of detemir therapy in diabetic cats in a general clinical setting. Fourteen diabetic cats with a follow-up period of at least 3 months were included. Data were collected from medical records at the University Hospital for Companion Animals, University of Copenhagen, Denmark. Thirteen of 14 cats achieved moderate or excellent control of clinical symptoms within the initial 3 months of detemir therapy, including five cats previously treated unsuccessfully with other types of insulin. Clinical improvements were noted after 1 month of therapy and continued over time. Three cats achieved remission within the initial 3 months and none experienced a diabetic relapse during the study period. One cat achieved remission after 13 months of therapy. Improvements in clinical symptoms were markedly better than indicated by blood glucose and serum fructosamine concentrations. The safety of detemir was very high, with only two reported episodes of clinical hypoglycaemia, neither of which required veterinary attention. Based on these results detemir can be recommended for the treatment of diabetic cats, including cats previously treated unsuccessfully with other types of insulin. © ISFM and AAFP 2014.

  18. Online Relinquishments of Dogs and Cats in Australia.

    Science.gov (United States)

    Hazel, Susan J; Jenvey, Caitlin J; Tuke, Jonathan

    2018-02-07

    While traditionally people relinquish their pets to an animal shelter or pound, the internet provides a newer method to re-home. We analyzed advertisements (ads) on the largest website in Australia for trading dogs and cats: Gumtree. Data was collected in 2016. Dogs were sampled on 7, 16 and 24 February 2016 and cats on 9, 19 and 26 February 2016, with 2640 ads for relinquished dogs, and 2093 ads for relinquished cats. It was estimated >31,000 puppies/dogs and >24,000 kittens/cats are relinquished on Gumtree per year. The median age of dogs was 1.42 and cats 0.9 years of age. There were 23% of dog ads and 62% of cat ads for free animals. Compared to the human population, there were proportionately more ads in Queensland and fewer ads in Victoria. A total of 15 people were surveyed who had relinquished a dog or cat using Gumtree. The dog owners used Gumtree for two reasons: because they believed the shelters were full (n = 4); and they wanted to see/interview the new owner (n = 2). For cat owners: they had originally got the cat on Gumtree (n = 2); they use Gumtree for other things, and it works (n = 2), and; they wanted to see/interview the new owner (n = 2). The data collected will be valuable for implementation of policy and interventions to protect the welfare of unwanted dogs and cats.

  19. The Population Origins and Expansion of Feral Cats in Australia

    Science.gov (United States)

    Yurchenko, Andrey A.; David, Victor A.; Scott, Rachael; Koepfli, Klaus-Peter; Driscoll, Carlos; O’Brien, Stephen J.; Menotti-Raymond, Marilyn

    2016-01-01

    The historical literature suggests that in Australia, the domestic cat (Felis catus) had a European origin [~200 years before present (ybp)], but it is unclear if cats arrived from across the Asian land bridge contemporaneously with the dingo (4000 ybp), or perhaps immigrated ~40000 ybp in association with Aboriginal settlement from Asia. The origin of cats in Australia is important because the continent has a complex and ancient faunal assemblage that is dominated by endemic rodents and marsupials and lacks the large placental carnivores found on other large continents. Cats are now ubiquitous across the entire Australian continent and have been implicit in the range contraction or extinction of its small to medium sized (cats using 15 short tandem repeat (STR) genomic markers. Their origin appears to come exclusively from European founders. Feral cats in continental Australia exhibit high genetic diversity in comparison with the low diversity found in populations of feral cats living on islands. The genetic structure is consistent with a rapid westerly expansion from eastern Australia and a limited expansion in coastal Western Australia. Australian cats show modest if any population structure and a close genetic alignment with European feral cats as compared to cats from Asia, the Christmas and Cocos (Keeling) Islands (Indian Ocean), and European wildcats (F. silvestris silvestris). PMID:26647063

  20. Development of the cat-owner relationship scale (CORS).

    Science.gov (United States)

    Howell, Tiffani J; Bowen, Jonathan; Fatjó, Jaume; Calvo, Paula; Holloway, Anna; Bennett, Pauleen C

    2017-08-01

    Characteristics of the human-animal bond can be influenced by both owner-related and pet-related factors, which likely differ between species. Three studies adapted the Monash Dog-Owner Relationship Scale (MDORS) to permit assessment of human-cat interactions as perceived by the cat's owner. In Study 1293 female cat owners completed a modified version of the MDORS, where 'dog' was replaced with 'cat' for all items. Responses were compared with a matched sample of female dog owners. A partial least squares discriminant analysis revealed systematic differences between cat and dog owners in the Dog (Cat)-Owner Interaction subscale (MDORS subscale 1), but not for Perceived Emotional Closeness or Perceived Costs (Subscales 2 and 3). Study 2 involved analysis of free-text descriptions of cat-owner interactions provided by 61 female cat owners. Text mining identified key words which were used to create additional questions for a new Cat-Owner Interaction subscale. In Study 3, the resulting cat-owner relationship scale (CORS) was tested in a group of 570 cat owners. The main psychometric properties of the scale, including internal consistency and factor structure, were evaluated. We propose that this scale can be used to accurately assess owner perceptions of their relationship with their cat. A modified scale, combining items from the CORS and MDORS (a C/DORS), is also provided for when researchers would find it desirable to compare human-cat and human-dog interactions. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

  2. Determinants of Cat Choice and Outcomes for Adult Cats and Kittens Adopted from an Australian Animal Shelter

    Science.gov (United States)

    Zito, Sarah; Paterson, Mandy; Vankan, Dianne; Morton, John; Bennett, Pauleen; Phillips, Clive

    2015-01-01

    Simple Summary Commonly, more adult cats than kittens are euthanized in animal shelters. We surveyed 382 cat adopters to assess adoption outcomes and potential determinants of adopters’ choice of cat age group and price. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and responsible ownership requirements. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive in all age and adoption price groups. This study provides evidence to inform the design of strategies to encourage adult cat adoptions. Abstract The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters’ cat age group choice (adult or kitten) and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6–12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of “low-cost” adoptions in populations, such as the study population, and lends support for the use of “low-cost” adoptions as an option for

  3. Determinants of Cat Choice and Outcomes for Adult Cats and Kittens Adopted from an Australian Animal Shelter

    Directory of Open Access Journals (Sweden)

    Sarah Zito

    2015-04-01

    Full Text Available The percentage of adult cats euthanized in animal shelters is greater than that of kittens because adult cats are less likely to be adopted. This study aimed to provide evidence to inform the design of strategies to encourage adult cat adoptions. One such strategy is to discount adoption prices, but there are concerns that this may result in poor adoption outcomes. We surveyed 382 cat adopters at the time of adoption, to assess potential determinants of adopters’ cat age group choice (adult or kitten and, for adult cat adopters, the price they are willing to pay. The same respondents were surveyed again 6–12 months after the adoption to compare outcomes between cat age groups and between adult cats in two price categories. Most adopters had benevolent motivations for adopting from the shelter and had put considerable thought into the adoption and requirements for responsible ownership. However, adult cat adopters were more likely to have been influenced by price than kitten adopters. Adoption outcomes were generally positive for both adult cats and kittens and for adult cats adopted at low prices. The latter finding alleviates concerns about the outcomes of “low-cost” adoptions in populations, such as the study population, and lends support for the use of “low-cost” adoptions as an option for attempting to increase adoption rates. In addition, the results provide information that can be used to inform future campaigns aimed at increasing the number of adult cat adoptions, particularly in devising marketing strategies for adult cats.

  4. A comparative neuroanatomical study of the red nucleus of the cat, macaque and human.

    Directory of Open Access Journals (Sweden)

    Satoru Onodera

    Full Text Available BACKGROUND: The human red nucleus (Nr is comparatively less well-studied than that of cats or monkeys. Given the functional importance of reticular and midbrain structures in control of movement and locomotion as well as from an evolutionary perspective, we investigated the nature and extent of any differences in Nr projections to the olivary complex in quadrupedal and bipedal species. Using neuroanatomical tract-tracing techniques we developed a "neural sheet" hypothesis allowing us to propose how rubro-olivary relations differ among the three species. METHODS AND FINDINGS: Wheat germ agglutinin-horseradish peroxidase staining supports findings that the cat's nucleus accessories medialis of Bechtrew (NB projects mainly to the lateral bend of the principal olive. We clarified boundaries among nucleus of Darkschewitsch (ND, NB and parvicellular red nucleus (pNr of the cat's neural sheet. The macaque's ND-medial accessory olivary projection is rostro-caudally organized and the dorsomedial and ventrolateral parts of the macaque's pNr may project to the principal olive's rostral and caudal dorsal lamella; in cat it projects as well to pNr. Myelin- and Nissl-stained sections show that a well-developed dorsomedial part of the human Nr consists of densely packed cells, deriving small myelinated fibers that continue into the medial central tegmental tract. CONCLUSIONS: Based on these findings we suggest there are distinct bipedal-quadrupedal differences for Nr projections to the olivary complex. We propose the Nr of cats and monkeys comprise the ND, NB and pNr in a zonal sheet-like structure, retaining clear nuclear boundaries and an isolated, well-developed mNr. The human NB may be distinguished from its more specialised ND (ND lies alongside a well-developed pNr in the human central gray. Phylogenetically, the NB may have been translocated into a roll-shaped Nr in the reticular formation, the dorsomedial portion of which might correspond to the cat

  5. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population.

    Science.gov (United States)

    Kesselheim, Aaron S; Franklin, Jessica M; Kim, Seoyoung C; Seeger, John D; Solomon, Daniel H

    2015-11-01

    A brand-name version of colchicine (Colcrys) was introduced after its manufacturer conducted a clinical trial in acute gout patients, leading to higher prices for this drug. We analyzed the impact of the new single-source colchicine product on prescribing and patient health spending as well as incidence rates of potentially dangerous concomitant use of clarithromycin and cyclosporine after formal FDA approval. We conducted a retrospective cohort study of UnitedHealth-affiliated enrollees newly diagnosed with gout or FMF. Among gout and FMF patients separately, we assessed linear trends in colchicine prescriptions, prescription drug costs, and total health care costs from 2009 to September 2010 (market exclusivity announced) compared to January 2011 (market exclusivity enforced) through 2012. Next, we estimated trends in co-prescription within 15 days of clarithromycin, azithromycin (indicated on the Colcrys label for use in place of clarithromycin), and cyclosporine. Among gout patients, before Colcrys' market exclusivity, the odds of receiving colchicine within 30 days of gout diagnosis increased 1.4 %/month (OR: 1.014, 95 % CI: 1.011-1.018). Following FDA action, the odds decreased by 0.5 %/month (OR: 0.995, 95 % CI: 0.992-0.999) (p colchicine changed from an increase of 2.8 %/month to a decrease by 7.6 %/month (p = 0.01). Patients receiving colchicine experienced increases in average monthly prescription drug costs ($418 vs. $651, p colchicine/clarithromycin co-prescription before and after FDA action did not change, while co-prescription of colchicine/cyclosporine increased after introduction of Colcrys [-0.75 monthly change in patients (95 % CI: -1.07, -0.43) vs. 0.13 (95 % CI: -0.16, 0.42), p colchicine initiation and an increase in patient spending. By contrast, we did not observe any association with improvements in avoidance of potentially dangerous co-prescriptions.

  6. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

    Directory of Open Access Journals (Sweden)

    Uebbing L

    2017-04-01

    Full Text Available Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contributed equally to this work Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is

  7. Mining FDA drug labels using an unsupervised learning technique--topic modeling.

    Science.gov (United States)

    Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

    2011-10-18

    The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific

  8. Mining FDA drug labels using an unsupervised learning technique - topic modeling

    Science.gov (United States)

    2011-01-01

    Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

  9. Development of an operational specific CAT risk (SCATR) index

    Science.gov (United States)

    Keller, J. L.; Haines, P. A.; Luers, J. K.

    1983-01-01

    The original formulations of Roach (1970) and Oard (1974) for the calculation of clear air turbulence (CAT) potential from synoptic scale data were extended. An index which gives a measure of the specific risk of encountering CAT - the specific clear air turbulence risk (SCATR) index - was defined. This index takes into account both the locally and advected contributions to the energy necessary for CAT. The advected contribution is associated with the role of atmospheric gravity waves. The SCATR index was calculated for a number of cases where documented encounters with CAT occurred. Of particular interest were those made for cases involving severe CAT. The results for the two severe CAT cases run were quite impressive and elicited considerable interest from operational aviation meteorologists.

  10. Ultrastructural myocardial changes in seven cats with spontaneous hypertrophic cardiomyopathy

    DEFF Research Database (Denmark)

    Christiansen, Liselotte Bruun; Prats Gavalda, Clara; Hyttel, Poul

    2015-01-01

    OBJECTIVES: Hypertrophic cardiomyopathy (HCM) is the most common heart disease in cats and shares clinical and pathological characteristics with human HCM. Little is known about the pathogenic mechanisms underlying development of spontaneous feline HCM. ANIMALS: The study population consisted...... of seven cats diagnosed with HCM and eight age-matched cats with no evidence of cardiac disease. METHODS: Fresh myocardial biopsies taken from the middle of the left ventricular posterior free wall were obtained and examined with transmission electron microscopy. RESULTS: Electron microscopic examination...... showed ultrastructural aberrations of the myocardial cytoarchitecture and of the interstitium in the seven cats with HCM. In the most severely affected cats the myofibrils were disorganized and subsarcolemmal mitochondria were depleted. In control cats, contraction band artifacts were commonly seen...

  11. Susceptibility of Domestic Cats to Chronic Wasting Disease

    Science.gov (United States)

    Nalls, Amy V.; Seelig, Davis M.; Kraft, Susan L.; Carnes, Kevin; Anderson, Kelly R.; Hayes-Klug, Jeanette; Hoover, Edward A.

    2013-01-01

    Domestic and nondomestic cats have been shown to be susceptible to feline spongiform encephalopathy (FSE), almost certainly caused by consumption of bovine spongiform encephalopathy (BSE)-contaminated meat. Because domestic and free-ranging nondomestic felids scavenge cervid carcasses, including those in areas affected by chronic wasting disease (CWD), we evaluated the susceptibility of the domestic cat (Felis catus) to CWD infection experimentally. Cohorts of 5 cats each were inoculated intracerebrally (i.c.) or orally (p.o.) with CWD-infected deer brain. At 40 and 42 months postinoculation, two i.c.-inoculated cats developed signs consistent with prion disease, including a stilted gait, weight loss, anorexia, polydipsia, patterned motor behaviors, head and tail tremors, and ataxia, and the cats progressed to terminal disease within 5 months. Brains from these two cats were pooled and inoculated into cohorts of cats by the i.c., p.o., and intraperitoneal and subcutaneous (i.p./s.c.) routes. Upon subpassage, feline CWD was transmitted to all i.c.-inoculated cats with a decreased incubation period of 23 to 27 months. Feline-adapted CWD (FelCWD) was demonstrated in the brains of all of the affected cats by Western blotting and immunohistochemical analysis. Magnetic resonance imaging revealed abnormalities in clinically ill cats, which included multifocal T2 fluid attenuated inversion recovery (FLAIR) signal hyperintensities, ventricular size increases, prominent sulci, and white matter tract cavitation. Currently, 3 of 4 i.p./s.c.- and 2 of 4 p.o. secondary passage-inoculated cats have developed abnormal behavior patterns consistent with the early stage of feline CWD. These results demonstrate that CWD can be transmitted and adapted to the domestic cat, thus raising the issue of potential cervid-to-feline transmission in nature. PMID:23236066

  12. Affectionate Interactions of Cats with Children Having Autism Spectrum Disorder

    Directory of Open Access Journals (Sweden)

    Lynette A. Hart

    2018-03-01

    Full Text Available Mental and physical benefits of dogs have been reported for adults and children with special needs, but less is known about benefits of cats for children. A cat that can be held by a child could provide important therapeutic companionship for children with severe or less severe autism spectrum disorder (ASD who otherwise may lack prosocial behaviors. Because relatively little is known about the behavior of cats around children, we conducted this study. Phase 1 gathered web-survey data from families having an adult cat and a child with ASD (n = 64. In Phase 2, there were direct telephone interviews of parents having a child with severe ASD (n = 16 or less severe ASD (n = 11, or typical development (n = 17. From the Phase 1 web survey of families with ASD children (full range of severities, affectionate interactions of the cats with children were common. Most parents with ASD children volunteered positive comments regarding the cat, such as calming the child, being a soothing protector or a guardian. In the interviews in Phase 2, for all three groups, most parents characterized cats as at least moderately affectionate toward the child. However, cats living with severe ASD children were reported to exhibit less affection than those living with typically developing children or children with less severe ASD. A minority of cats in each group showed some aggression to the specified child; this was not elevated with ASD children. Responses suggested that the cats adopted as kittens were more affectionate and less aggressive to all categories of children than those adopted as adults. Overall, participants reported that ASD children’s behaviors indicated that they valued the relationship with the cat, similar to typically developing children, pointing to the importance and potential usefulness of selecting affectionate and compatible cats for ASD children.

  13. Transient post-traumatic hemidiaphragmatic paralysis in two cats.

    Science.gov (United States)

    Vignoli, M; Toniato, M; Rossi, F; Terragni, R; Manzini, M; Franchi, A; Pozzi, L

    2002-07-01

    A diagnosis of post-traumatic hemidiaphragmatic paralysis was made in two cats. Both cats had a history of trauma and paradoxical inward movement of the abdominal wall at inspiration. Thoracic radiographs were taken at inspiration and expiration. Although the images were suggestive of hemidiaphragmatic paralysis, definitive diagnosis was reached by fluoroscopy in one cat and by ultrasonography in the second. Both cases resolved spontaneously and diaphragmatic function was normal at follow-up.

  14. Affectionate Interactions of Cats with Children Having Autism Spectrum Disorder.

    Science.gov (United States)

    Hart, Lynette A; Thigpen, Abigail P; Willits, Neil H; Lyons, Leslie A; Hertz-Picciotto, Irva; Hart, Benjamin L

    2018-01-01

    Mental and physical benefits of dogs have been reported for adults and children with special needs, but less is known about benefits of cats for children. A cat that can be held by a child could provide important therapeutic companionship for children with severe or less severe autism spectrum disorder (ASD) who otherwise may lack prosocial behaviors. Because relatively little is known about the behavior of cats around children, we conducted this study. Phase 1 gathered web-survey data from families having an adult cat and a child with ASD ( n  = 64). In Phase 2, there were direct telephone interviews of parents having a child with severe ASD ( n  = 16) or less severe ASD ( n  = 11), or typical development ( n  = 17). From the Phase 1 web survey of families with ASD children (full range of severities), affectionate interactions of the cats with children were common. Most parents with ASD children volunteered positive comments regarding the cat, such as calming the child, being a soothing protector or a guardian. In the interviews in Phase 2, for all three groups, most parents characterized cats as at least moderately affectionate toward the child. However, cats living with severe ASD children were reported to exhibit less affection than those living with typically developing children or children with less severe ASD. A minority of cats in each group showed some aggression to the specified child; this was not elevated with ASD children. Responses suggested that the cats adopted as kittens were more affectionate and less aggressive to all categories of children than those adopted as adults. Overall, participants reported that ASD children's behaviors indicated that they valued the relationship with the cat, similar to typically developing children, pointing to the importance and potential usefulness of selecting affectionate and compatible cats for ASD children.

  15. RadCat 2.0 User Guide.

    Energy Technology Data Exchange (ETDEWEB)

    Osborn, Douglas.; Weiner, Ruth F.; Mills, George Scott; Hamp, Steve C.; O' Donnell, Brandon, M.; Orcutt, David J.; Heames, Terence J.; Hinojosa, Daniel

    2005-01-01

    This document provides a detailed discussion and a guide for the use of the RadCat 2.0 Graphical User Interface input file generator for the RADTRAN 5.5 code. The differences between RadCat 2.0 and RadCat 1.0 can be attributed to the differences between RADTRAN 5 and RADTRAN 5.5 as well as clarification for some of the input parameters. 3

  16. Polycystic kidney disease in a family of Persian cats.

    Science.gov (United States)

    Biller, D S; Chew, D J; DiBartola, S P

    1990-04-15

    A 6-year-old Persian cat was determined to have polycystic kidney disease (PKD). Because of 3 previous clinical reports of PKD in Persian cats, the offspring were examined by use of ultrasonography, which provided evidence of PKD in 3 of the 4 offspring. Because of the genetic transmission of this disease, breeders should be advised not to breed PKD-positive Persian cats.

  17. A CASE OF POLYCYSTIC KIDNEY DISEASE IN A PERSIAN CAT

    OpenAIRE

    KARABAGLI, Murat; AKDOGAN KAYMAZ, Alev

    2012-01-01

    ABSTRACT Feline polycystic kidney disease (PKD) is an inherited autosomal dominant disease that has been identified in Persian cats and Persian related breeds such as the Exotic Shorthair cats. PKD has been reported sporadically in the veterinary literature and progress asymptomaticly until the renal deficiency is observed. Diagnosis of the PKD can be carried out by abdominal ultrasonography and DNA test in 7 weeks old. Our case was a 7 years old male Persian cat which had been brought to Dep...

  18. Renal disease in cats infected with feline immunodeficiency virus.

    Science.gov (United States)

    Baxter, K J; Levy, J K; Edinboro, C H; Vaden, S L; Tompkins, M B

    2012-01-01

    Feline immunodeficiency virus (FIV) and human immunodeficiency virus (HIV) infection cause similar clinical syndromes of immune dysregulation, opportunistic infections, inflammatory diseases, and neoplasia. Renal disease is the 4th most common cause of death associated with HIV infection. To investigate the association between FIV infection and renal disease in cats. Client-owned cats (153 FIV-infected, 306 FIV-noninfected) and specific-pathogen-free (SPF) research colony cats (95 FIV-infected, 98 FIV-noninfected). A mixed retrospective/prospective cross-sectional study. Blood urea nitrogen (BUN), serum creatinine, urine specific gravity (USG), and urine protein:creatinine ratio (UPC) data were compared between FIV-infected and FIV-noninfected cats. In FIV-infected cats, total CD4+ and CD8+ T lymphocytes were measured using flow cytometry, and CD4+:CD8+ T lymphocyte ratio was calculated. Renal azotemia was defined as a serum creatinine ≥ 1.9 mg/dL with USG ≤ 1.035. Proteinuria was defined as a UPC > 0.4 with an inactive urine sediment. Among the client-owned cats, no association was detected between FIV infection and renal azotemia (P = .24); however, a greater proportion of FIV-infected cats were proteinuric (25.0%, 16 of 64 cats) compared to FIV-noninfected cats (10.3%, 20 of 195 cats) (P FIV-infected cats, but UPC was positively correlated with the CD4+:CD8+ T lymphocyte ratio (Spearman's rho = 0.37, P = .01). Among the SPF research colony cats, no association was detected between FIV infection and renal azotemia (P = .21) or proteinuria (P = .25). Proteinuria but not azotemia was associated with natural FIV infection. Copyright © 2012 by the American College of Veterinary Internal Medicine.

  19. Resistive index for kidney evaluation in normal and diseased cats.

    Science.gov (United States)

    Tipisca, Vlad; Murino, Carla; Cortese, Laura; Mennonna, Giuseppina; Auletta, Luigi; Vulpe, Vasile; Meomartino, Leonardo

    2016-06-01

    The objectives were to determine the resistive index (RI) in normal cats and in cats with various renal diseases, and to evaluate the effect of age on RI. The subjects were cats that had ultrasonography (US) of the urinary tract and RI measurement at our centre between January 2003 and April 2014. Based on clinical evaluation, biochemical and haematological tests, urinalysis and US, the cats were classified as healthy or diseased. RI measurements were made from the interlobar or arcuate arteries. Data were analysed for differences between the right and the left kidney, the two sexes, different age groups in healthy cats, and between healthy and diseased cats. A total of 116 cats (68 males, 48 females) were included: 24 healthy and 92 diseased. In the healthy cats, RI (mean ± SD) differed significantly (P = 0.02) between the right kidney (0.54 ± 0.07) and the left kidney (0.59 ± 0.08). For the left kidney, RI was significantly higher in cats with chronic kidney disease (0.73 ± 0.12) and acute kidney injury (0.72 ± 0.08) (P = 0.0008). For the right kidney, RI was significantly higher in cats with chronic kidney disease (0.72 ± 0.11), acute kidney injury (0.74 ± 0.08), polycystic kidney disease (0.77 ± 0.11) and renal tumour (0.74 ± 0.001) (P cats, useful in the differential diagnosis of diffuse renal diseases. While it does not change with the age of the cat, ultrasonographers should be aware that RI may differ between the two kidneys. © ISFM and AAFP 2015.

  20. Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme.

    Science.gov (United States)

    Ourso, André

    2012-01-01

    Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.

  1. Frenchay dysarthria assessment (FDA-2) in Parkinson's disease: cross-cultural adaptation and psychometric properties of the European Portuguese version.

    Science.gov (United States)

    Cardoso, Rita; Guimarães, Isabel; Santos, Helena; Loureiro, Rita; Domingos, Josefa; de Abreu, Daisy; Gonçalves, Nilza; Pinto, Serge; Ferreira, Joaquim

    2017-01-01

    Hypokinetic dysarthria is a common symptom in those with Parkinson's disease (PD); there is currently no standardized or validated tool for assessing speech in this population. To translate into European Portuguese (EP) the FDA-2 and perform a cultural adaptation followed by an evaluation of its psychometric properties in PD in a sample of people with PD in different stages of disease progression. Translation, back-translation, experts' analysis, pre-test and final version test were performed. The EP version of the FDA-2 was administered to 80 people with PD (PwP) with dysarthria, feasibility and acceptability, reliability (internal consistency and inter-rater reliability) and validity (face and convergent) were measured. Overall, the EP-FDA-2 proved to be similar to the original demonstrating the same conceptual meanings, semantics, idiomatic and score equivalences. It has good feasibility (missing data dysarthria in PD in clinical practice as in the research field.

  2. An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

    Science.gov (United States)

    Strauss, Debra M

    2011-01-01

    This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.

  3. The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care.

    Science.gov (United States)

    Jazowski, Shelley A; Winn, Aaron N

    2017-06-01

    The Food and Drug Administration (FDA) is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA. Extensive review times coupled with the demand for necessary treatments have prompted the policymakers to implement measures to speed medical devices to market.The purpose of this review is to summarize the evolution of the regulatory pathways through which medical devices utilized in diabetes care gain market access. Regulatory pathways, ranging from premarket notification to premarket approval, require distinct, yet necessary ("least burdensome") evidence demonstrating a device's safety and effectiveness. Collaboration between manufacturers, regulators, and patients has resulted in the development and approval of novel diabetes care devices, including the first hybrid closed-loop artificial pancreas. Policy provisions, ranging from the least burdensome approach to the "breakthrough device" expedited pathway, aim to balance innovation, access, and safety. Clinicians must be aware of the evolving regulatory landscape and play an active role in enhancing patient safety.

  4. Chiron Vision files FDA application to market intraocular implant for CMV retinitis. Food and Drug Administration.

    Science.gov (United States)

    1995-07-01

    Chiron Corporation and Hoffman-LaRoche announced a filing of a New Drug Application with the Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of CMV retinitis. Clinical trials show that Vitrasert offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye. One study reported that the median time to progression of CMV retinitis was 186 days for eyes receiving Vitrasert compared to 72 days for eyes receiving intravenous ganciclovir therapy. Chiron's intraocular implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug into the eye for up to eight months. Two additional trials are underway. For further information contact the Professional Services Group at Chiron Corporation at (800) 244-7668, select 2.

  5. An analysis of FDA-approved drugs: natural products and their derivatives.

    Science.gov (United States)

    Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton

    2016-02-01

    Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Implications and challenges for implementation of the FDA's final deeming rule for waterpipe tobacco.

    Science.gov (United States)

    Sutfin, Erin L; Soule, Eric K; McKelvey, Karma; Jenson, Desmond

    2017-06-30

    For the first time, the Food and Drug Administration's (FDAs) Center for Tobacco Products now has regulatory authority over all tobacco products, including waterpipe tobacco. In the rule expanding its authority to cover all tobacco products, the FDA uses largely a one-size-fits-all approach. However, several aspects of waterpipe tobacco smoking make it unique from other tobacco products, which may require more specific, tailored rules. This paper describes the distinct features of waterpipe tobacco products and accessories, and identifies unique challenges to the current regulation posed by this form of tobacco use. Additionally, we highlight the need for further research-generated evidence to support additional rulemaking. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Potential reduction exposure products and FDA tobacco and regulation: a CNS call to action.

    Science.gov (United States)

    Heath, Janie; Andrews, Jeannette; Balkstra, Cindy R

    2004-01-01

    A new generation of tobacco harm reduction products is stirring controversy and confusion among healthcare providers. These products, known as "potential reduction exposure products" (PREPs), can be described in terms of reported scientific evidence, as "the good, the bad, and the ugly." On the good side, there is sufficient scientific evidence to support the use of Commit, a new over-the-counter nicotine lozenge PREP, approved for smoking cessation. On the bad side, there is no scientific evidence to support the use of Ariva, another over-the-counter nicotine lozenge PREP, marketed as an alternative to cigarettes when smoking is restricted. On the ugly side, both of these PREPs are nicotine delivery systems with "candy-like" appearances; however, one (Commit) has the Food and Drug Administration (FDA) approval and the other (Ariva) does not. This article provides an overview of PREPs and strategies to help clinical nurse specialists (CNSs) address tobacco harm reduction issues.

  8. Ultrasonographic features of intestinal adenocarcinoma in five cats

    International Nuclear Information System (INIS)

    Rivers, B.J.; Walter, P.A.; Feeney, D.A.; Johnston, G.R.

    1997-01-01

    Adenocarcinoma, followed by lymphosarcoma, are the most common feline intestinal neoplasms. Clinicopathological, survey radiographic, and ultrasonographic findings of five cats with intestinal adenocarcinoma are reported. An abdominal mass was palpable in all five cats, but the mass could be localized to bowel in only two cats. Radiographically an abdominal mass was detected in only one cat. Ultrasonographically there was a segmental intestinal mural mass in all five cats. The mass was characterized by circumferential bowel wall thickening with transmural loss of normal sonographic wall layers. In one cat, the circumferential symmetric hypoechoic bowel wall thickening was similar to that reported for segmental lymphoma. In the other four cats, the sonographic features of the thickened bowel wall were varied, being mixed echogenicity and asymmetric in 3 cats and mixed echogenicity and symmetric in one. The results of the present report suggest that sonographic observation of mixed echogenicity segmental intestinal wall thickening in the cat represents adenocarcinoma rather than lymphosarcoma, although other infiltrative diseases should be considered

  9. Fibrinous pericarditis secondary to bacterial infection in a cat.

    Science.gov (United States)

    Tagawa, Michihito; Kurashima, Chihiro; Shimbo, Genya; Omura, Hiroshi; Koyama, Kenji; Horiuchi, Noriyuki; Kobayashi, Yoshiyasu; Kawamoto, Keiko; Miyahara, Kazuro

    2017-06-10

    A three-year-old spayed domestic short-haired cat presented for evaluation of weight loss, cardiomegaly and pleural effusion. Echocardiographic examination demonstrated a thickened pericardium with mild pericardial effusion and a large volume of pleural effusion characterized by exudate. Although the cat was treated with antibiotics, the clinical symptoms did not improve. The cat developed dyspnea and died on day 7. Necropsy revealed a large amount of modified transudates ascites, pleural effusion and markedly dilated pericardium. Histopathological examination revealed severe exudation of fibrin and granulation tissue in a thick layer of the epicardium. The cat was diagnosed with fibrinous pericarditis secondary to bacterial infection.

  10. Radiographic assessment of laryngeal reflexes in ketamine-anesthetized cats

    International Nuclear Information System (INIS)

    Robinson, E.P.; Johnston, G.R.

    1986-01-01

    The competence of the laryngeal closure reflexes of cats anesthetized with ketamine was assessed. Radiographic evaluations of the respiratory and digestive tracts were made after colloidal barium suspension was instilled into the pharynges of conscious and ketamine-anesthetized cats. There was a significant ketamine dose-related response of spread of contrast medium into the supraglottic laryngeal area and into the stomach 2 minutes after contrast medium was instilled into the pharynx (P less than 0.05). Cats did not aspirate contrast medium into the lower respiratory tract. Three ketamine-anesthetized cats aspirated contrast medium into the subglottic area of the larynx, and 2 of these cats also aspirated the material into the cranial part of the trachea. This material was coughed up and swallowed within 5 minutes. Transit time of contrast medium into the stomach seemed to be increased in 11 of the 15 cats given the larger dosages of ketamine (24, 36, 48 mg/kg of body weight), compared with that in conscious cats and those given ketamine at 12 mg/kg. Competent laryngeal protective reflexes in cats can be maintained with ketamine anesthesia. Contrast radiography could be used as a diagnostic aid in ketamine-anesthetized cats suspected of laryngeal reflex abnormalities

  11. [Uroliths of cats in Switzerland from 2002 to 2009].

    Science.gov (United States)

    Gerber, B; Brandenberger-Schenk, F; Rothenanger, E; Müller, C

    2016-10-01

    In this study data on composition of uroliths collected from cats and epidemiologic data of affected cats in Switzerland from 2002 to 2009 are summarised. Of 884 stones analysed 50% (n=441) were composed of calcium oxalate, 45% (n=398) of struvite, 3% (n=18) of ammonium urate, 1% (n=12) were mixed stones, 1% (n=9) were composed of silica, 3 stones were solidified blood, 2 consisted of cystine and 1of xanthine. 40% of the ureteral stones were composed of struvite. Domestic cats had significantly less calcium oxalate stones compared to British Shorthair or Persian cats. Cats with calcium oxalate stones were older and cats with struvite stones were younger than other affected cats. Female and male cats were equally affected with stones. Compared to studies from other countries, in Switzerland silica stones occurred more often and ureteral stones were more often composed of Struvite. The present study shows that occurrence and prevalence of urinary calculi of cats from Switzerland exhibited only slight differences to studies from other countries.

  12. Online Relinquishments of Dogs and Cats in Australia

    Science.gov (United States)

    Jenvey, Caitlin J.; Tuke, Jonathan

    2018-01-01

    Simple Summary The aim of this study was to analyze dog and cat advertisements on a popular online trading website in Australia in February 2016. A total of 2640 ads for dogs and 2093 ads for cats were classified as being relinquished on Gumtree. A total of 23% of dog ads and 62% of cat ads were for free animals. The median age was 1.42 years in dogs and 0.9 years in cats. Compared to the human population there were proportionately more ads in Queensland and fewer ads in Victoria. In comparison to pets from animal shelters advertised on PetRescue, there were more purebred dogs on Gumtree, although the common breeds were similar. Fifteen people who had relinquished a dog or cat on Gumtree were interviewed. They used Gumtree because they believed shelters were full, they wanted to see/interview the new owner, or because they originally got the animal on Gumtree and it works. These results shed light on a hitherto under-studied population of relinquished dogs and cats. Abstract While traditionally people relinquish their pets to an animal shelter or pound, the internet provides a newer method to re-home. We analyzed advertisements (ads) on the largest website in Australia for trading dogs and cats: Gumtree. Data was collected in 2016. Dogs were sampled on 7, 16 and 24 February 2016 and cats on 9, 19 and 26 February 2016, with 2640 ads for relinquished dogs, and 2093 ads for relinquished cats. It was estimated >31,000 puppies/dogs and >24,000 kittens/cats are relinquished on Gumtree per year. The median age of dogs was 1.42 and cats 0.9 years of age. There were 23% of dog ads and 62% of cat ads for free animals. Compared to the human population, there were proportionately more ads in Queensland and fewer ads in Victoria. A total of 15 people were surveyed who had relinquished a dog or cat using Gumtree. The dog owners used Gumtree for two reasons: because they believed the shelters were full (n = 4); and they wanted to see/interview the new owner (n = 2). For cat

  13. Cats are not small dogs: the emergence of feline medicine.

    Science.gov (United States)

    Lynn, Amy

    2006-11-01

    Cats have finally garnered the attention they deserve in veterinary medicine, however, there is still much to learn about this unique species and new challenges surface daily. For example, at the time of writing, avian influenza in cats is being closely monitored by world veterinary and health officials. Controversial topics, such as how to manage the homeless cat population, declawing, and cloning will continue to spark active debate. However, the future appears promising for cats as more veterinarians, researchers, and organizations increase their focus on felines.

  14. Repurposed FDA-approved drugs targeting genes influencing aging can extend lifespan and healthspan in rotifers.

    Science.gov (United States)

    Snell, Terry W; Johnston, Rachel K; Matthews, Amelia B; Zhou, Hongyi; Gao, Mu; Skolnick, Jeffrey

    2018-04-01

    Pharmaceutical interventions can slow aging in animals, and have advantages because their dose can be tightly regulated and the timing of the intervention can be closely controlled. They also may complement environmental interventions like caloric restriction by acting additively. A fertile source for therapies slowing aging is FDA approved drugs whose safety has been investigated. Because drugs bind to several protein targets, they cause multiple effects, many of which have not been characterized. It is possible that some of the side effects of drugs prescribed for one therapy may have benefits in retarding aging. We used computationally guided drug screening for prioritizing drug targets to produce a short list of candidate compounds for in vivo testing. We applied the virtual ligand screening approach FINDSITE comb for screening potential anti-aging protein targets against FDA approved drugs listed in DrugBank. A short list of 31 promising compounds was screened using a multi-tiered approach with rotifers as an animal model of aging. Primary and secondary survival screens and cohort life table experiments identified four drugs capable of extending rotifer lifespan by 8-42%. Exposures to 1 µM erythromycin, 5 µM carglumic acid, 3 µM capecitabine, and 1 µM ivermectin, extended rotifer lifespan without significant effect on reproduction. Some drugs also extended healthspan, as estimated by mitochondria activity and mobility (swimming speed). Our most promising result is that rotifer lifespan was extended by 7-8.9% even when treatment was started in middle age.

  15. Synergy testing of FDA-approved drugs identifies potent drug combinations against Trypanosoma cruzi.

    Directory of Open Access Journals (Sweden)

    Joseph D Planer

    2014-07-01

    Full Text Available An estimated 8 million persons, mainly in Latin America, are infected with Trypanosoma cruzi, the etiologic agent of Chagas disease. Existing antiparasitic drugs for Chagas disease have significant toxicities and suboptimal effectiveness, hence new therapeutic strategies need to be devised to address this neglected tropical disease. Due to the high research and development costs of bringing new chemical entities to the clinic, we and others have investigated the strategy of repurposing existing drugs for Chagas disease. Screens of FDA-approved drugs (described in this paper have revealed a variety of chemical classes that have growth inhibitory activity against mammalian stage Trypanosoma cruzi parasites. Aside from azole antifungal drugs that have low or sub-nanomolar activity, most of the active compounds revealed in these screens have effective concentrations causing 50% inhibition (EC50's in the low micromolar or high nanomolar range. For example, we have identified an antihistamine (clemastine, EC50 of 0.4 µM, a selective serotonin reuptake inhibitor (fluoxetine, EC50 of 4.4 µM, and an antifolate drug (pyrimethamine, EC50 of 3.8 µM and others. When tested alone in the murine model of Trypanosoma cruzi infection, most compounds had insufficient efficacy to lower parasitemia thus we investigated using combinations of compounds for additive or synergistic activity. Twenty-four active compounds were screened in vitro in all possible combinations. Follow up isobologram studies showed at least 8 drug pairs to have synergistic activity on T. cruzi growth. The combination of the calcium channel blocker, amlodipine, plus the antifungal drug, posaconazole, was found to be more effective at lowering parasitemia in mice than either drug alone, as was the combination of clemastine and posaconazole. Using combinations of FDA-approved drugs is a promising strategy for developing new treatments for Chagas disease.

  16. Development of hybrid fog detection algorithm (FDA) using satellite and ground observation data for nighttime

    Science.gov (United States)

    Kim, So-Hyeong; Han, Ji-Hae; Suh, Myoung-Seok

    2017-04-01

    In this study, we developed a hybrid fog detection algorithm (FDA) using AHI/Himawari-8 satellite and ground observation data for nighttime. In order to detect fog at nighttime, Dual Channel Difference (DCD) method based on the emissivity difference between SWIR and IR1 is most widely used. DCD is good at discriminating fog from other things (middle/high clouds, clear sea and land). However, it is difficult to distinguish fog from low clouds. In order to separate the low clouds from the pixels that satisfy the thresholds of fog in the DCD test, we conducted supplementary tests such as normalized local standard derivation (NLSD) of BT11 and the difference of fog top temperature (BT11) and air temperature (Ta) from NWP data (SST from OSTIA data). These tests are based on the larger homogeneity of fog top than low cloud tops and the similarity of fog top temperature and Ta (SST). Threshold values for the three tests were optimized through ROC analysis for the selected fog cases. In addition, considering the spatial continuity of fog, post-processing was performed to detect the missed pixels, in particular, at edge of fog or sub-pixel size fog. The final fog detection results are presented by fog probability (0 100 %). Validation was conducted by comparing fog detection probability with the ground observed visibility data from KMA. The validation results showed that POD and FAR are ranged from 0.70 0.94 and 0.45 0.72, respectively. The quantitative validation and visual inspection indicate that current FDA has a tendency to over-detect the fog. So, more works which reducing the FAR is needed. In the future, we will also validate sea fog using CALIPSO data.

  17. Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

    Directory of Open Access Journals (Sweden)

    Majid Moshirfar

    2017-09-01

    Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

  18. Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

    Science.gov (United States)

    Moshirfar, Majid; Desautels, Jordan D; Wallace, Ryan T; Koen, Nicholas; Hoopes, Phillip C.

    2017-01-01

    AIM To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED) submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA), adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE), and achieved monocular uncorrected near visual acuity (UNVA) at 24mo. RESULTS Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40) or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20) or better at 24mo. CONCLUSION Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article. PMID:28944206

  19. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers.

    Science.gov (United States)

    Lowes, Steve; Ackermann, Bradley L

    2016-02-01

    Crystal City VI Workshop on Bioanalytical Method Validation of Biomarkers, Renaissance Baltimore Harborplace Hotel, Baltimore, MD, USA, 28-29 September 2015 The Crystal City VI workshop was organized by the American Association of Pharmaceutical Scientists in association with the US FDA to continue discussion on the bioanalysis of biomarkers. An outcome of the Crystal City V workshop, convened following release of the draft FDA Guidance for Industry on Bioanalytical Methods Validation in 2013 was the need to have further discussion on biomarker methods. Biomarkers ultimately became the sole focal point for Crystal City VI, a meeting attended by approximately 200 people and composed of industry scientists and regulators from around the world. The meeting format included several panel discussions to maximize the opportunity for dialogue among participants. Following an initial session on the general topic of biomarker assays and intended use, more focused sessions were held on chromatographic (LC-MS) and ligand-binding assays. In addition to participation by the drug development community, significant representation was present from clinical testing laboratories. The experience of this latter group, collectively identified as practitioners of CLIA (Clinical Laboratory Improvement Amendments), helped shape the discussion and takeaways from the meeting. While the need to operate within the framework of the current BMV guidance was clearly acknowledged, a general understanding that biomarker methods validation cannot be adequately depicted by current PK-centric guidelines emerged as a consensus from the meeting. This report is not intended to constitute the official proceedings from Crystal City VI, which is expected to be published in early 2016.

  20. Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database

    Science.gov (United States)

    Fuller, Andrew; Vilos, George A.; Pautler, Stephen E.

    2012-02-01

    Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

  1. Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

    Science.gov (United States)

    Esterly, John S; Steadman, Emily; Scheetz, Marc H

    2011-06-01

    In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

  2. Cigarette graphic warning labels and smoking prevalence in Canada: a critical examination and reformulation of the FDA regulatory impact analysis.

    Science.gov (United States)

    Huang, Jidong; Chaloupka, Frank J; Fong, Geoffrey T

    2014-03-01

    The estimated effect of cigarette graphic warning labels (GWL) on smoking rates is a key input to the Food and Drug Administration's (FDA) regulatory impact analysis (RIA), required by law as part of its rule-making process. However, evidence on the impact of GWLs on smoking prevalence is scarce. The goal of this paper is to critically analyse FDA's approach to estimating the impact of GWLs on smoking rates in its RIA, and to suggest a path forward to estimating the impact of the adoption of GWLs in Canada on Canadian national adult smoking prevalence. A quasi-experimental methodology was employed to examine the impact of adoption of GWLs in Canada in 2000, using the USA as a control. We found a statistically significant reduction in smoking rates after the adoption of GWLs in Canada in comparison with the USA. Our analyses show that implementation of GWLs in Canada reduced smoking rates by 2.87-4.68 percentage points, a relative reduction of 12.1-19.6%; 33-53 times larger than FDA's estimates of a 0.088 percentage point reduction. We also demonstrated that FDA's estimate of the impact was flawed because it is highly sensitive to the changes in variable selection, model specification, and the time period analysed. Adopting GWLs on cigarette packages reduces smoking prevalence. Applying our analysis of the Canadian GWLs, we estimate that if the USA had adopted GWLs in 2012, the number of adult smokers in the USA would have decreased by 5.3-8.6 million in 2013. Our analysis demonstrates that FDA's approach to estimating the impact of GWLs on smoking rates is flawed. Rectifying these problems before this approach becomes the norm is critical for FDA's effective regulation of tobacco products.

  3. Utilization trends of cervical artificial disc replacement after FDA approval compared with anterior cervical fusion: adoption of new technology.

    Science.gov (United States)

    Lu, Young; McAnany, Steven J; Hecht, Andrew C; Cho, Samuel K; Qureshi, Sheeraz A

    2014-02-01

    Epidemiologic study. To compare the utilization of anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) in terms of patient and hospital characteristics during the 3 years after Food and Drug Administration (FDA) approval of CDA devices in 2007. There was a surge in CDA adoption in the 3 years prior to FDA approval of CDA devices in 2007. However, utilization trends of CDA versus ACDF since the FDA approval are unknown. The Nationwide Inpatient Sample database was used to identify CDA and ACDF procedures performed in the United States in the 3 years after FDA approval of CDA devices (2008-2010). The frequencies of CDA and ACDF were estimated, stratified by patient and hospital characteristics. Average length of hospital stay and total charges and costs were estimated. Multivariable analysis was performed to identify patient and hospital characteristics associated with CDA utilization. In the 3 years after FDA approval of cervical disc devices, population-adjusted growth rates for CDA and ACDF were 4.9% and 11.8%, respectively (P = 0.6977). Female, African American and Medicaid patients were less likely to receive CDA. CDA was less likely to be performed in patients with cervical spondylotic changes and more likely to be performed in younger and healthier patients. CDA was less likely to be performed in the Midwestern United States or in public hospitals. The prevalence of CDA increased in the 3 years after FDA approval with a growth rate that is approximately twice than that for ACDF. Although there seems to be CDA adoption, CDA growth seemed to have reached a plateau and ACDF still remained the dominant surgical strategy for cervical disc disease. Possible regional, racial, and sex disparities in CDA utilization and a more strict approach in the selection of CDA over traditional ACDF may have impeded rapid adoption of CDA. 3.

  4. Medical management of gastrinoma in a cat

    Directory of Open Access Journals (Sweden)

    Michael Lane

    2016-04-01

    Full Text Available Case summary A 7-year-old male castrated domestic short-haired cat was evaluated for a 4 week history of intermittent vomiting, ptyalism, lethargy and weight loss. Serum biochemistry revealed mild mixed hepatopathy. Abdominal ultrasonography identified multiple heterogeneous hepatic masses and a linear, hyperechoic focus with associated reverberation artifact in the wall of the stomach consistent with a gastric ulcer. Serum gastrin concentrations were markedly increased. Cytologic interpretation of a fine-needle aspirate of the hepatic masses was consistent with neuroendocrine neoplasia, and a diagnosis of gastrinoma was established. Deterioration of the cat’s condition, despite at-home acid-suppressant therapy, led to hospitalization. The cat was initially stabilized with intravenous crystalloid fluid therapy, maropitant, pantoprazole and octreotide. A continuous radiotelemetric intragastric pH monitoring system was used to monitor the response of intragastric pH to therapy. Long-term therapy was continued with omeprazole (orally q12h, octreotide (subcutaneously q8h and thrice-weekly toceranib administered orally. Toceranib therapy led to gastrointestinal upset and was discontinued. Gastric ulceration resolved within 8 weeks, and palliation of clinical signs was achieved for approximately 5 months. Relevance and novel information Including this report, only six cases of feline gastrinoma have been reported in the veterinary literature. Little is known regarding non-surgical therapy, and octreotide has not been previously reported for medical management of feline gastrinoma. Results of intragastric pH monitoring and clinical improvement suggest that medical therapy using octreotide and proton pump inhibitors represents a novel therapeutic option for cats with gastrinoma where surgical excision is not feasible.

  5. Scotopic electroretinography in fishing cat (Prionailurus viverrinus) and leopard cat (Prionailurus bengalensis).

    Science.gov (United States)

    Sussadee, Metita; Vorawattanatham, Narathip; Pinyopummin, Anuchai; Phavaphutanon, Janjira; Thayananuphat, Aree

    2017-05-01

    To establish baseline normal scotopic electroretinograpic (ERG) parameters for two wild cat species: fishing cats (FC) and leopard cats (LC). Twelve normal, FC and eight LC kept in the Chiang Mai Night Safari Zoo, Thailand. The mean ages of FC and LC were 7.08 and 5.00 years, respectively. All animals were studied using a standard scotopic protocol of a portable, handheld, multi-species electroretinography (HMsERG). There were significant differences in the means of ERG b-wave amplitude of the rod response (Rod, 0.01 cd.s/m 2 ), a- and b-wave amplitudes of standard light intensity of rod and cone response (Std R&C, 3 cd.s/m 2 ) and b-wave amplitude of high light intensity of rod and cone response (Hi-int R&C, 10 cd.s/m 2 ) with LC having higher amplitudes than FC. There was no significant difference in a- and b- wave implicit time except for the b-wave of Hi-int (P=0.03). No significant differences were observed in b/a amplitude ratios. Data from this report provides reference values for scotopic ERG measurements in these two wild cat species. It showed that the normal scotopic ERG responses have some differences between the two species which might be due to the skull conformation, eye size or physiology of the retina. © 2016 American College of Veterinary Ophthalmologists.

  6. CATS Deliverable 2.2 : CATS car-to-cyclist accident parameters and test scenarios

    NARCIS (Netherlands)

    Uittenbogaard, J.; Camp, O.M.G.C. op den; Montfort, S. van

    2016-01-01

    This report summarizes the work conducted within work package (WP) 2 "Test scenario definition" of the CATS project. It describes relevant accident parameters for the 5 most dominant accidents scenarios defined in WP1. The objective of this WP2 is to construct car-to-cyclist accident test scenarios

  7. CATS Deliverable 1.2 : CATS car-to-cyclist accident scenarios

    NARCIS (Netherlands)

    Uittenbogaard, J.; Rodarius, C.; Camp, O.M.G.C. op den

    2016-01-01

    This report summarizes the work conducted within work package (WP) 1 "accident analysis" of the CATS project. It describes the collection of data, the analyses as well as the final accident scenarios. The objective of this WP was to analyse car-to-cyclist accident scenarios in the EU, mainly

  8. Chronic pancreatitis in dogs and cats.

    Science.gov (United States)

    Xenoulis, Panagiotis G; Suchodolski, Jan S; Steiner, Jorg M

    2008-03-01

    Pancreatitis is the most common disorder of the exocrine pancreas in dogs and cats. Clinical diagnosis of chronic pancreatitis is challenging because the disease is usually mild or subclinical and because its clinical signs are often the same as those of complicating or concurrent diseases. Obtaining a detailed history, performing a thorough physical examination, and conducting tests that are sensitive and specific for pancreatitis are crucial in diagnosing chronic pancreatitis. Initial management of an acute episode of chronic pancreatitis largely involves supportive and dietary measures, while long-term management of chronic pancreatitis is based on dietary modification. Management of complications and concurrent diseases is crucial in animals with chronic pancreatitis.

  9. Cat eye syndrome with hypogonadotropic hypogonadism.

    Science.gov (United States)

    Masukawa, H; Ozaki, T; Nogimori, T

    1998-10-01

    A 17-year-old male diagnosed as having Cat Eye Syndrome (CES) with hypogonadotropic hypogonadism showed short stature and no development of secondary sex characteristics. Exogeneous gonadotropin replacement therapy combining human chorionic gonadotropin (hCG) and human menopausal gonadotropin (hMG) was started. As a result, the short stature and androgen deficiency were relieved. The critical region of CES was tetrasomy of 22 pter-->q11. Abnormalities of other chromosomes which cause hypogonadotropic hypogonadism may exist, thus further investigation is needed.

  10. Eurytrema procyonis and pancreatitis in a cat.

    Science.gov (United States)

    Vyhnal, Kristin K; Barr, Stephen C; Hornbuckle, William E; Yeager, Amy E; Wade, Susan E; Frongillo, Marguerite F; Simpson, Kenneth W; Bowman, Dwight D

    2008-08-01

    A young adult male domestic shorthair cat was presented for physical examination, routine vaccinations, and a fecal examination. Physical examination revealed no significant abnormalities. Eggs of the raccoon pancreatic fluke Eurytrema procyonis were detected by fecal flotation. Results of a complete blood count and serum biochemistry panel were normal. Abdominal sonography revealed an enlarged hypoechoic pancreas with a hyperechoic rim, and a distended and thickened pancreatic duct. Serum pancreatic lipase immunoreactivity (PLI) was increased. These findings supported the possibility of fluke-associated pancreatitis. Treatment with praziquantel/pyrantel/febantel was associated with resolution of sonographic abnormalities and normalization of PLI.

  11. Prostatic abscess in a neutered cat.

    Science.gov (United States)

    Mordecai, Adam; Liptak, Julius M; Hofstede, Tamara; Stalker, Margaret; Kruth, Stephen

    2008-01-01

    A 6-year-old, male castrated domestic shorthair cat was presented for evaluation of lethargy, vomiting, anorexia, and constipation. Physical examination revealed an elevated body temperature and an extramural colonic mass. Abdominal ultrasonography demonstrated a hypoechoic mass measuring 2.2 cm in maximum dimension immediately caudal to the bladder. Cytological evaluation of a fine-needle aspirate confirmed the mass was a prostatic abscess. Abdominal celiotomy and prostatic omentalization were successful in resolving clinical abnormalities. Feline prostatic abscessation is a rare condition that has not been previously reported and may have a good outcome if treated early and appropriately.

  12. Post incisional hernia in dogs and cats

    OpenAIRE

    Raiser, Alceu Gaspar

    1999-01-01

    A hérnia pós-incisão foi analisada quanto à prevalência e protocolo terapêutico em nove cães e seis gatos cadastrados no Hospital Veterinário da Universidade Federal de Santa Maria, RS, Brasil. Os animais apresentaram peritonite localizada que foi tratada com reposição hidroeletrolítica, antibioticoterapia, irrigação abundante da cavidade abdominal e debridamento cirúrgico. Todos tiveram evolução favorável.The case records of nine dogs and six cats with post-incisional hernia were managed by ...

  13. Spontaneaous linear gastric tears in a cat.

    Science.gov (United States)

    Gualtieri, M; Olivero, D; Costa Devoti, C

    2015-09-01

    An 11-year-old female cat presented for chronic vomiting. Endoscopy revealed an altered gastric mucosa and spontaneous formation of linear gastric tears during normal organ insufflations. The histopathological diagnosis was atrophic gastritis with Helicobacter pylori infection. Medical treatment permitted a complete resolution of clinical signs. The linear tears observed resembled gastric lesions rarely reported in humans, called "Mallory-Weiss syndrome". To the authors' knowledge this is the first report of spontaneous linear gastric tears in animals. © 2015 British Small Animal Veterinary Association.

  14. EDITORIAL: Perspectives Perspectives

    Science.gov (United States)

    Dewhurst, Richard

    2011-05-01

    In this issue, we are delighted to publish the second in a series of articles under the banner of Perspectives. The series commenced in late 2008, when Udo Kaatze [1] published an article about the powerful technique of dielectric spectrometry for liquid measurements. In addition to examining the very wide frequency range from 10-6 Hz to 10-13 Hz, an outline of possible future developments was presented. Some challenging tasks for the future were briefly outlined. The format of the article was different to the usual style of a contributed paper or review article. Instead, it represented a short summary of recent work in the field and offered a viewpoint of an expert in the area. Its commentary noted several milestones that had been recently achieved, and then looked to the future. The Perspective format allowed the author to provide some opinion about the challenges of the future not normally permitted in a Topical Review. The journal now intends to publish several more Perspectives. For example, in this issue David Birch [2] presents a Perspective about another important measurement science, namely fluorescence detections and their future directions. These are based on an old technique which provided the basis for detecting the presence of molecular species. Successful research led to an understanding and description of the phenomenon of molecular fluorescence in terms of excited state energies, transitions, symmetries and rate parameters. More recently, using fluorescence as a probe, and with the exploitation of new technologies, new applications have included the study of protein, vision, photosynthesis, membranes and DNA. Indeed nowhere has fluorescence had more impact than in the biosciences. Once again, the intention of the Perspective article has been to highlight recent milestones within the field. Importantly, it also indicates some of the future challenges. Such Perspectives are an occasional series. They are not intended to deflect from the balance of

  15. Evaluation of plasma islet amyloid polypeptide and serum glucose and insulin concentrations in nondiabetic cats classified by body condition score and in cats with naturally occurring diabetes mellitus.

    Science.gov (United States)

    Henson, Michael S; Hegstad-Davies, Rebecca L; Wang, Qi; Hardy, Robert M; Armstrong, P Jane; Jordan, Kathryn; Johnson, Kenneth H; O'Brien, Timothy D

    2011-08-01

    To evaluate and compare circulating concentrations of islet amyloid polypeptide (IAPP), insulin, and glucose in nondiabetic cats classified by body condition score (BCS) and in cats with naturally occurring diabetes mellitus. 109 (82 nondiabetic, 21 nonketoacidotic diabetic, and 6 ketoacidotic diabetic) cats. Cats were examined and BCSs were assessed on a scale of 1 to 9. After food was withheld for 12 hours, blood was collected and plasma concentrations of IAPP and serum concentrations of insulin and glucose were measured. Differences in these values were evaluated among nondiabetic cats grouped according to BCS and in diabetic cats grouped as ketoacidotic or nonketoacidotic on the basis of clinicopathologic findings. Correlations were determined among variables. In nondiabetic cats, BCS was significantly and positively correlated with circulating IAPP and insulin concentrations. Mean plasma IAPP concentrations were significantly different between cats with BCSs of 5 and 7, and mean serum insulin concentrations were significantly different between cats with BCSs of 5 and 8. Serum glucose concentrations were not significantly different among nondiabetic cats. Mean IAPP concentrations were similar between nonketoacidotic diabetic cats and nondiabetic cats with BCSs of 8 or 9. Mean IAPP concentrations were significantly reduced in ketoacidotic diabetic cats, compared with those of nondiabetic cats with BCSs of 6 through 8 and of nonketoacidotic diabetic cats. Results indicated that increased BCS (a measure of obesity) is associated with increased circulating concentrations of IAPP and insulin in nondiabetic cats.

  16. Overweight in adult cats: a cross-sectional study.

    Science.gov (United States)

    Öhlund, Malin; Palmgren, Malin; Holst, Bodil Ström

    2018-01-19

    Overweight in cats is a major risk factor for diabetes mellitus and has also been associated with other disorders. Overweight and obesity are believed to be increasing problems in cats, as is currently seen in people, with important health consequences. The objectives of the present study were to determine the prevalence of overweight in cats from two different cohorts in a cross-sectional study design and to assess associations between overweight and diagnoses, and between overweight and demographic and environmental factors. Data were obtained from medical records for cats (n = 1072) visiting an academic medical center during 2013-2015, and from a questionnaire on insured cats (n = 1665). From the medical records, information on body condition score, breed, age, sex, neutering status, and diagnosis was obtained. The questionnaire included questions relating to the cat's body condition, breed, age, sex, neutering status, outdoor access, activity level, and diet. Data were analyzed by multivariable logistic regression. The prevalence of overweight was 45% in the medical records cohort and 22% in the questionnaire cohort, where owners judged their pet's body condition. Overweight cats in the medical records cohort were more likely to be diagnosed with lower urinary tract disease, diabetes mellitus, respiratory disease, skin disorders, locomotor disease, and trauma. Eating predominantly dry food, being a greedy eater, and inactivity were factors associated with an increased risk of overweight in the final model in the questionnaire cohort. In both cohorts, the Birman and Persian breeds, and geriatric cats, were less likely to be overweight, and male cats were more likely to be overweight. The prevalence of overweight cats (45%) as assessed by trained personnel was high and in the same range as previously reported. Birman and Persian cats had a lower risk of overweight. The association with dry food found in adult, neutered cats is potentially important because

  17. The prevalence and significance of hyperglycemia in hospitalized cats.

    Science.gov (United States)

    Ray, Casey C; Callahan-Clark, Julie; Beckel, Nicole F; Walters, Patricia C

    2009-08-01

    To report the prevalence of hyperglycemia in cats admitted to a veterinary hospital and to determine if hyperglycemic cats had increased morbidity and mortality when compared with normoglycemic cats. DESIGN - Retrospective clinical study. Community-based referral hospital. Nondiabetic cats admitted to the hospital. None. The medical records of nondiabetic cats admitted to the hospital over a 1-year period were reviewed. There were 182 cats that met the criteria for inclusion in the study. Information obtained included signalment, length of hospitalization, initial and highest blood glucose measurement, diagnosis, treatment, and final disposition. Sixty-three percent of cats (116/182) were hyperglycemic at the time of presentation. Total incidence of hyperglycemia at any point during hospitalization was 64% (118/182). No association was found between hyperglycemia either initially or at any point during the hospitalization and mortality. However, a significant association was documented between the presence of hyperglycemia and increased length of hospitalization (LOH) (P=0.04). The duration of LOH was also significantly associated with the degree of hyperglycemia (P=0.01). A number of different disease processes were represented in the study population. However, the number of cats in each disease category was small and no association could be found between any of them and blood glucose affecting mortality and morbidity. The prevalence of hyperglycemia in feline patients admitted to a primary referral hospital was 64%. Cats with hyperglycemia had a longer LOH when compared with normoglycemic cats; however, presence of hyperglycemia did not impact mortality in this population of cats. © Veterinary Emergency and Critical Care Society 2009.

  18. CATS Cloud and Aerosol Level 2 Heritage Edition Data Products.

    Science.gov (United States)

    Rodier, S. D.; Vaughan, M.; Yorks, J. E.; Palm, S. P.; Selmer, P. A.; Hlavka, D. L.; McGill, M. J.; Trepte, C. R.

    2017-12-01

    The Cloud-Aerosol Transport System (CATS) instrument was developed at NASA's Goddard Space Flight Center (GSFC) and deployed to the International Space Station (ISS) in January 2015. The CATS elastic backscatter lidars have been operating continuously in one of two science modes since February 2015. One of the primary science objectives of CATS is to continue the CALIPSO aerosol and cloud profile data record to provide continuity of lidar climate observations during the transition from CALIPSO to EarthCARE. To accomplish this, the CATS project at NASA's Goddard Space Flight Center (GSFC) and the CALIPSO project at NASA's Langley Research Center (LaRC) closely collaborated to develop and deliver a full suite of CALIPSO-like level 2 data products using the latest version of the CALIPSO level 2 Version 4 algorithms for the CATS data acquired while operating in science mode 1 (Multi-beam backscatter detection at 1064 and 532 nm, with depolarization measurement at both wavelengths). In this work, we present the current status of the CATS Heritage (i.e. CALIPSO-like) level 2 data products derived from the recent released CATS Level 1B V2-08 data. Extensive comparisons are performed between the three data sets (CALIPSO V4.10 Level 2, CATS Level 2 Operational V2-00 and CATS Heritage V1.00) for cloud and aerosol measurements (e.g., cloud-top height cloud-phase, cloud-layer occurrence frequency and cloud-aerosol discrimination) along the ISS path. In addition, global comparisons (between 52°S and 52°N) of aerosol extinction profiles derived from the CATS Level 2 Operational products and CALIOP V4 Level 2 products are presented. Comparisons of aerosol optical depths retrieved from active sensors (CATS and CALIOP) and passive sensors (MODIS) will provide context for the extinction profile comparisons.

  19. Bartonella infection in shelter cats and dogs and their ectoparasites.

    Science.gov (United States)

    Tsai, Yi-Lun; Lin, Chao-Chen; Chomel, Bruno B; Chuang, Shih-Te; Tsai, Kun-Hsien; Wu, Wen-Jer; Huang, Chin-Gi; Yu, Jiann-Chung; Sung, Min-Hua; Kass, Philip H; Chang, Chao-Chin

    2011-08-01

    Mainly through vector transmission, domestic cats and dogs are infected by several Bartonella spp. and represent a large reservoir for human infections. This study investigated the relationship of prevalences of Bartonella infection in shelter dogs and cats and various ectoparasite species infesting them (fleas, ticks, and lice). Moreover, relationships between Bartonella infection and animal gender and age and presence of ectoparasites were analyzed. Blood samples were collected from 120 dogs and 103 cats. There were 386 ticks and 36 fleas harvested on these dogs, and 141 fleas, 4 ticks, and 2 lice harvested on these cats. Isolation/detection of Bartonella sp. was performed by culture, polymerase chain reaction (PCR), and partial sequencing. Bartonella was isolated from 21 (20.4%) cats and detected by PCR from 20 (19.4%) cats, 2 (1.7%) dogs, 55 (39%) fleas collected from cats, 28 (10%) ticks DNA samples, and 1 (2.8%) flea collected from dogs. When combining culture and PCR data, 27 cats and 55 fleas collected on cats were positive for Bartonella henselae or Bartonella clarridgeiae, but none were coinfected. Approximately half of the B. henselae isolates from 21 cats were B. henselae type I. Moreover, B. henselae, Bartonella phoceensis, Bartonella queenslandensis, Bartonella rattimassiliensis, Bartonella elizabethae DNA was detected in ticks collected from dogs and one flea was B. clarridgeiae PCR positive. This is the first report of such a wide variety of Bartonella spp. detected in Rhipicephalus sanguineus. Further studies are required to understand the relative importance of these ectoparasites to transmit Bartonella spp. in dogs and cats.

  20. La Juventud Obrera Católica y la política: entre la lealtad peronista y la identidad católica

    Directory of Open Access Journals (Sweden)

    Jessica Blanco

    2012-12-01

    Full Text Available Este trabajo analiza el posicionamiento político de la Juventud Obrera Católica (JOC y el proceso de configuración de identidades políticas de sus miembros entre 1943 y 1955. Así, se propone un abordaje desde dos perspectivas complementarias: a través del discurso y el accionar de la JOC a nivel institucional y a partir de la mirada de sus militantes, una visión forjada al calor de un proceso de conformación de la identidad peronista. Las fuentes utilizadas fueron el periódico de la JOC, Juventud Obrera, y la interpretación de testimonios orales de antiguos dirigentes de la asociación.This paper deals with the political positioning of the Juventud Obrera Católica (JOC and the configuration process of the political identities of their members between 1943 an 1955. So, we propose an approach from two complementary perspectives: through the speech and actions at the institutional level and from the look of its members, a vision forged in the heat of the forming process of the Peronist identity. The sources used were the news paper of the JOC, Juventud Obrera, and several oral testimonies from formers leaders of the association.

  1. Acromegaly in a non-diabetic cat

    Directory of Open Access Journals (Sweden)

    Federico Fracassi

    2016-04-01

    Full Text Available Case summary A 14-year-old, neutered male European shorthair cat was evaluated for a routine health check. The owner did not report any clinical signs except for respiratory stridor. On physical examination the main findings were broad facial features and increased interdental spaces. On haematology, a mild, non-regenerative anaemia was detected, whereas the serum biochemistry profile and urinalysis were unremarkable. The serum glucose concentration was within the reference interval. Serum insulin-like growth factor-1 concentration was markedly elevated (>1600 ng/ml. The basal serum growth hormone concentration was elevated and decreased only mildly after somatostatin administration. Basal serum insulin concentration was high, and the insulin concentration increased considerably after glucose loading, consistent with insulin resistance. CT scanning of the skull showed an enlarged pituitary gland and increased skull bone thickness. The final diagnosis was acromegaly. Relevance and novel information These findings demonstrate that acromegaly should be pursued and suspected in cats other than those with diabetes mellitus.

  2. Serum Beta Hydroxybutyrate Concentrations in Cats with Chronic Kidney Disease, Hyperthyroidism, or Hepatic Lipidosis

    OpenAIRE

    Gorman, L.; Sharkey, L.C.; Armstrong, P.J.; Little, K.; Rendahl, A.

    2016-01-01

    Background Ketones, including beta hydroxybutyrate (BHB), are produced in conditions of negative energy balance and decreased glucose utilization. Serum BHB concentrations in cats are poorly characterized in diseases other than diabetes mellitus. Hypothesis Serum BHB concentrations will be increased in cats with chronic kidney disease (CKD), hyperthyroidism (HT), or hepatic lipidosis (HL). Animals Twenty?eight client?owned cats with CKD, 34 cats with HT, and 15 cats with HL; 43 healthy cats. ...

  3. 33 CFR 117.1001 - Cat Point Creek.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Cat Point Creek. 117.1001 Section 117.1001 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY BRIDGES DRAWBRIDGE OPERATION REGULATIONS Specific Requirements Virginia § 117.1001 Cat Point Creek. The draw of the...

  4. The Population Origins and Expansion of Feral Cats in Australia.

    Science.gov (United States)

    Spencer, Peter B S; Yurchenko, Andrey A; David, Victor A; Scott, Rachael; Koepfli, Klaus-Peter; Driscoll, Carlos; O'Brien, Stephen J; Menotti-Raymond, Marilyn

    2016-03-01

    The historical literature suggests that in Australia, the domestic cat (Felis catus) had a European origin [~200 years before present (ybp)], but it is unclear if cats arrived from across the Asian land bridge contemporaneously with the dingo (4000 ybp), or perhaps immigrated ~40000 ybp in association with Aboriginal settlement from Asia. The origin of cats in Australia is important because the continent has a complex and ancient faunal assemblage that is dominated by endemic rodents and marsupials and lacks the large placental carnivores found on other large continents. Cats are now ubiquitous across the entire Australian continent and have been implicit in the range contraction or extinction of its small to medium sized (Australia exhibit high genetic diversity in comparison with the low diversity found in populations of feral cats living on islands. The genetic structure is consistent with a rapid westerly expansion from eastern Australia and a limited expansion in coastal Western Australia. Australian cats show modest if any population structure and a close genetic alignment with European feral cats as compared to cats from Asia, the Christmas and Cocos (Keeling) Islands (Indian Ocean), and European wildcats (F. silvestris silvestris). © The American Genetic Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Effectiveness of the Domestic Cat (Felis silvestris catus) Urine ...

    African Journals Online (AJOL)

    The stored cat urine was then thawed and mixed with maize starch to form a thick dough and then granulated and dried at room temperature before being packed in a hermetically closed jar. Initially, rodent foot marks on tracking soot coat tiles were used to estimate the rat population before the cat urine extracts application.

  6. The French CAT: An Assessment of Its Empirical Validity.

    Science.gov (United States)

    Burston, Jack

    1995-01-01

    Investigates the empirical validity of the Monash-Melbourne computer adaptive test for French (French CAT). The article focuses on the accuracy of the French CAT as a tool for streaming incoming university students into three levels of a first-year (post-high school) French course. The test is demonstrated to be a good predictor of short-term…

  7. Simple nonparametric checks for model data fit in CAT

    NARCIS (Netherlands)

    Meijer, R.R.

    2005-01-01

    In this paper, the usefulness of several nonparametric checks is discussed in a computerized adaptive testing (CAT) context. Although there is no tradition of nonparametric scalability in CAT, it can be argued that scalability checks can be useful to investigate, for example, the quality of item

  8. Bacteriology of the Anterior Genitalia of the Domestic House Cat ...

    African Journals Online (AJOL)

    The bacteriology of the anterior genitalia of the domestic house cat was determined using vaginal swabs collected from sixty apparently healthy female domestic cats (20 kittens, 20 pregnant and 20 non-pregnant adults). The swabs were streaked on blood agar, Mac Conkey agar and eosin methylene blue agar plates ...

  9. Pancreatic function in domestic cats with pancreatic fluke infection.

    Science.gov (United States)

    Fox, J N; Mosley, J G; Vogler, G A; Austin, J L; Reber, H A

    1981-01-01

    Thirty-one of 290 cats (10.7%) from the area around St Louis, Mo, were infected with Eurytrema procyonis. In some cats, the pancreas was severely affected, with almost complete atrophy and fibrous replacement of the gland. Both bicarbonate and protein secretions were impaired, although clinically evident pancreatic insufficiency was not seen.

  10. Abdominal (liver, spleen) and bone manifestations of cat scratch disease

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, C.E.; Patrick, L.E. (Egleston Children' s Hospital, Emory Univ., Atlanta, GA (United States). Dept. of Radiology)

    1992-09-01

    Cat scratch disease is usually a self-limiting illness. Patients may develop systemic complications including hepatic granulomas, splenic abscesses, mesenteric adenitis, osteolytic lesions, as well as dermatologic and CNS complications. In this paper the literature is reviewed and two cases are discussed which present the imaging findings in patients with hepatic, splenic, mesenteric, and bony manifestations of cat scratch disease. (orig.).

  11. Cat scratch disease presenting as orbital abscess and osteomyelitis.

    Science.gov (United States)

    Mirakhur, Beloo; Shah, Samir S; Ratner, Adam J; Goldstein, Scott M; Bell, Louis M; Kim, Jean O

    2003-08-01

    Ocular manifestations of cat scratch disease are uncommon. The diagnosis is usually made on the basis of increasing Bartonella henselae serum antibody titers. We report a child presenting with orbital abscess and osteomyelitis who was diagnosed with hepatosplenic cat scratch disease by detection of B. henselae DNA in the orbital abscess fluid.

  12. Felinine excretion in domestic cat breeds: a preliminary investigation.

    NARCIS (Netherlands)

    Hagen - Plantinga, Esther; Hendriks, Wouter; Bosch, Guido

    2014-01-01

    The aim of this study was to determine possible differences in felinine excretion between domesticated cat breeds. For this purpose, urine was collected from a total of 83 privately owned entire male cats from eight different breeds in the Netherlands during the period of November 2010 till November

  13. Using the Domestic Cat in the Teaching of Genetics.

    Science.gov (United States)

    Kinnear, Judith F.

    1986-01-01

    Focuses on genetic concepts that form key components of transmission genetics and illustrates how the domestic cat can be used in the teaching of these concepts. Offers examples of how laboratory experiences with the cat can enhance student learning of genetics. (ML)

  14. Population genetic analysis of cat populations from Mexico ...

    Indian Academy of Sciences (India)

    Unknown

    In this paper we identify new genetic profiles of eight Latin American cat populations. In addition, we combine data from the present study and previously published data on 70 other American and European populations to discuss (1) the points of introduction of mutant alleles for cat coat phenotypes from Europe into Latin ...

  15. Plasma amylin and insulin concentrations in normoglycemic and hyperglycemic cats.

    Science.gov (United States)

    Lutz, T A; Rand, J S

    1996-01-01

    The recently discovered pancreatic peptide amylin is postulated to be involved in the pathogenesis of feline diabetes mellitus. However, plasma amylin concentrations in normal and diabetic cats have not yet been published. The aim of the present study was to validate a commercial amylin radioimmunoassay kit for the measurement of feline amylin in unextracted plasma, and to measure plasma amylin concentrations in normal and diabetic cats. The kit had satisfactory specificity, sensitivity, accuracy, and precision, and can be recommended for measurement of feline amylin in unextracted EDTA plasma, when nonspecific binding of plasma samples is used in the calculation of measured amylin concentration. Fasting amylin concentration in cats with normal glucose tolerance was 97 +/- 4 pmol/L. Plasma amylin increased in parallel with insulin after glucose administration in cats with normal and impaired glucose tolerance. In contrast to cats with normal glucose tolerance, cats with impaired glucose tolerance had markedly delayed amylin and insulin secretion. Diabetic cats had basal hypoinsulinemia combined with hyperamylinemia. Hyperamylinemia may lead to reduced insulin secretion and insulin resistance, and contribute to the development of feline diabetes. In conclusion, feline amylin can be measured in unextracted EDTA plasma. Fasting amylin concentrations are approximately 100 pmol/L, and amylin and insulin are cosecreted in cats with normal and impaired glucose tolerance. Increased amylin concentrations may contribute to the development of feline diabetes mellitus.

  16. Isolation of Actinobacillus suis from a cat's lung

    DEFF Research Database (Denmark)

    Daignault, D.; Chouinard, L.; Møller, Kristian

    1999-01-01

    Actinobacillus suis has been isolated from the lungs of a 9-month-old cat. The bacterium was characterized biochemically as well as genetically, and its sensitivity profile to different antimicrobial agents was established. The role of this isolate in the cat's condition is discussed....

  17. Symmetric Dimethylarginine in Cats with Hypertrophic Cardiomyopathy and Diabetes Mellitus

    DEFF Research Database (Denmark)

    Langhorn, R.; Kieler, I. N.; Koch, J.

    2018-01-01

    Background: Symmetric dimethylarginine (SDMA) has been increasingly used as a marker of early chronic kidney disease (CKD) in cats, but little is known about the influence of comorbidities on SDMA in this species. Hypothesis: Hypertrophic cardiomyopathy (HCM) and diabetes mellitus (DM), independe...... controls, a finding that needs further investigation and should be kept in mind when evaluating renal function of cats with this endocrinopathy....

  18. Investigations on the immunopathogenesis of atopic dermatitis in cats

    NARCIS (Netherlands)

    Roosje, Pieternella Janna

    2002-01-01

    The term atopic dermatitis (AD) is commonly used in cats. At present, however, there is little known about the pathogenesis of feline AD. The aim was to investigate various aspects of the immunopathogenesis in a defined group of cats with signs and symptoms of atopic dermatitis and compare our

  19. Molecular cloning and sequence analysis of the cat myostatin gene ...

    African Journals Online (AJOL)

    ... MEF3, MTBF, PAX3, SMAD, HBOX, HOMF and TEAF motifs. Comparative analysis for some motifs showed both conservations and differences among cat, horse, porcine and human. Key words: Cat, myostatin 5'-regulatory region, molecular cloning, sequence analysis and comparison, transcription factor binding sites.

  20. European consensus statement on leptospirosis in dogs and cats

    Science.gov (United States)

    Leptospirosis is a zoonotic disease of worldwide distribution affecting most mammalian species. Clinical leptospirosis is common in dogs but seems to be rare in cats. Both dogs and cats however, can shed leptospires in the urine. This is problematic as it can lead to exposure of humans. The control ...