WorldWideScience

Sample records for biothrax product approval

  1. Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on...

  2. Establishment approval in international trade of animal products

    NARCIS (Netherlands)

    Rau, M.L.; Ge, L.; Valeeva, N.I.; Wagenberg, van C.P.A.

    2012-01-01

    This report provides an overview of different approaches of establishment approval as well as its implementation and organisation in international agrifood trade. The focus is on animal products as establishment approval is particularly used for exporting these products. Based on trade data, 8 count

  3. 75 FR 62387 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-10-08

    ... AGENCY Pesticide Product Registrations; Conditional Approval AGENCY: Environmental Protection Agency (EPA...., to conditionally register the pesticide products Paladin Technical, Paladin, and Paladin EC... provisions of section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),...

  4. Inactive ingredient Search for Approved Drug Products

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final...

  5. 14 CFR 21.333 - Issue of export airworthiness approval tags for Class III products.

    Science.gov (United States)

    2010-01-01

    ... for Class III products. 21.333 Section 21.333 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... Approvals § 21.333 Issue of export airworthiness approval tags for Class III products. (a) An applicant is entitled to an export airworthiness approval tag for Class III products if that applicant shows, except...

  6. 78 FR 57407 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol Petroleum Product Service, has been approved to gauge...

  7. 78 FR 57406 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2013-09-18

    ... SECURITY U.S. Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial... approval of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given, pursuant to CBP regulations, that Altol ] Petroleum Product Service, has been approved to gauge...

  8. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of... holders of an approved drug or biological product to change the product labeling to reflect certain types... biological product to change the product labeling to reflect certain types of newly acquired information...

  9. 48 CFR 4.1302 - Acquisition of approved products and services for personal identity verification.

    Science.gov (United States)

    2010-10-01

    ... products and services for personal identity verification. 4.1302 Section 4.1302 Federal Acquisition... Verification 4.1302 Acquisition of approved products and services for personal identity verification. (a) In... products and services. (b) Agencies may acquire the approved products and services from the GSA,...

  10. 17 CFR 40.3 - Voluntary submission of new products for Commission review and approval.

    Science.gov (United States)

    2010-04-01

    ... transaction execution facility may request that the Commission approve a new or dormant product prior to... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Voluntary submission of new products for Commission review and approval. 40.3 Section 40.3 Commodity and Securities Exchanges...

  11. [Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

    Science.gov (United States)

    Niimi, Shingo

    2015-01-01

    Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

  12. 77 FR 2308 - Approval of Altol Petroleum Product Service, as a Commercial Gauger

    Science.gov (United States)

    2012-01-17

    ... SECURITY Customs and Border Protection Approval of Altol Petroleum Product Service, as a Commercial Gauger... of Altol Petroleum Product Service, as a commercial gauger. SUMMARY: Notice is hereby given that, pursuant to 19 CFR 151.13, Altol Petroleum Product Service, Parque Industrial Sabanetas, Edificio M-...

  13. 75 FR 61497 - Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request...

    Science.gov (United States)

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable...'' (biosimilar) to, or ``interchangeable'' with, an FDA-licensed biological product. The purpose of this public... for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed...

  14. 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.

  15. 78 FR 14636 - Food Ingredients and Sources of Radiation Listed and Approved for Use in the Production of Meat...

    Science.gov (United States)

    2013-03-07

    ... used in combination with other approved ingredients to inhibit the growth of Listeria monocytogenes (Lm... in formulating new products while protecting the food supply against Listeria. Moreover,...

  16. 76 FR 20363 - Accreditation and Approval of Atlantic Product Services, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2011-04-12

    ... SECURITY U.S. Customs and Border Protection Accreditation and Approval of Atlantic Product Services, Inc... Homeland Security. ACTION: Notice of accreditation and approval of Atlantic Product Services, Inc., as a... 151.13, Atlantic Product Services, Inc., 2 Terminal Road Building OB2, Carteret, NJ 07008, has...

  17. 75 FR 35805 - Pesticide Product Registrations; Conditional Approvals

    Science.gov (United States)

    2010-06-23

    ... applications from Monsanto Company, 800 North Lindbergh Boulevard, St. Louis, MO 63167, to register pesticide... announced that Monsanto Company had submitted applications to register pesticide products containing the new... comment opposed granting Monsanto Company rights to produce, sell, or manufacture pesticide...

  18. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for......

  19. Drug discovery prospect from untapped species: indications from approved natural product drugs.

    Directory of Open Access Journals (Sweden)

    Feng Zhu

    Full Text Available Due to extensive bioprospecting efforts of the past and technology factors, there have been questions about drug discovery prospect from untapped species. We analyzed recent trends of approved drugs derived from previously untapped species, which show no sign of untapped drug-productive species being near extinction and suggest high probability of deriving new drugs from new species in existing drug-productive species families and clusters. Case histories of recently approved drugs reveal useful strategies for deriving new drugs from the scaffolds and pharmacophores of the natural product leads of these untapped species. New technologies such as cryptic gene-cluster exploration may generate novel natural products with highly anticipated potential impact on drug discovery.

  20. 14 CFR 193.17 - How must design and production approval holders handle information they receive from the FAA...

    Science.gov (United States)

    2010-01-01

    ... REGULATIONS PROTECTION OF VOLUNTARILY SUBMITTED INFORMATION § 193.17 How must design and production approval... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false How must design and production approval holders handle information they receive from the FAA under this part? 193.17 Section 193.17...

  1. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

  2. Quality assurance in production and use of special form radioactive material - focal points in BAM approvals

    Energy Technology Data Exchange (ETDEWEB)

    Rolle, A.; Buhlemann, L. [Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin (Germany)

    2004-07-01

    BAM as the competent authority for approval of special form radioactive material attaches great importance to a detailed audit of the required quality assurance programs for design, manufacture, testing, documentation, use, maintenance and inspection. Applicants have to submit, together with application documentation information on general arrangements for quality assurance, as well as on quality assurance in production and in operation. Fields where BAM has often found deficiencies are leak test methods, weld seam quality and the safety level after use.

  3. Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera

    Science.gov (United States)

    Watanabe, Natsumi; Yano, Kazuo; Tsuyuki, Kenichiro; Okano, Teruo; Yamato, Masayuki

    2015-01-01

    The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicines Agency had only ever reviewed three marketing authorization applications for gene therapy medicinal products. Unlike in the case of Glybera, the applications of the first two products, Cerepro and Contusugene Ladenovec Gendux/Advexin, both of which were for cancer diseases, were withdrawn. In this report, we studied the European public assessment reports of the three gene therapy products. During the assessment process, Glybera was re-examined and reviewed for a fourth time. We therefore researched the re-examination procedure of the European Union regulatory process. Approximately 25% of the new medicinal products initially given negative opinions from the Committee for Medicinal Products for Human Use were ultimately approved after re-examination from 2009 to 2013. The indications of most medicines were changed during the re-examination procedure, and the products were later approved with a mode of approval. These results suggested that the re-examination system in the European Union contributed to the approval of both several new drugs and the first gene therapy product. PMID:26052534

  4. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.

    Science.gov (United States)

    Green, William

    2013-01-01

    The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.

  5. 49 CFR 236.1013 - PTC Development Plan and Notice of Product Intent content requirements and Type Approval.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false PTC Development Plan and Notice of Product Intent... TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Positive Train Control Systems § 236.1013 PTC Development Plan and Notice of Product Intent content requirements and Type Approval. (a) For a PTC system...

  6. Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.

    Science.gov (United States)

    Chang, Yang; Burckart, Gilbert J; Lesko, Lawrence J; Dowling, Thomas C

    2013-09-01

    Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners.

  7. Policy plan for the early approval for irradiated meat products and the promotion of irradiated meats in market

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Ju Woon [Team for Radiation Food Science and Biotechnology, Advanced Radiation Technology Institute, Korea Atomic Energy Research Institute, Jeongeup (Korea, Republic of); Kim, Wang Geun [Ministry of Education, Science and Technology, Seoul (Korea, Republic of); Kim, Kyong Su [Dept. of Food and Nutrition, Chosun University, Gwangju (Korea, Republic of); Yook, Hong Sun [Dept. of Food and Nutrition, Chungnam National University, Daejeon (Korea, Republic of); Kim, Cheon Jei [Division of Animal Life Science, Konkuk University, Seoul (Korea, Republic of)

    2008-11-15

    The consumption of meat products is gradually being increased by the development of livestock raising technology, industrialized farm management and international trade. This increased consumption also created new market for ready-to-eat and ready-to-cook meat products. However, these convenience meat products can be easily contaminated during the processing and storage by pathogens, and there have been many reported cases of food borne illness by meats. One of the most effective methods for the decontamination of meat products is the radiation technology. Food irradiation was the established, well-recognized and safe sterilization method. Many other countries researched the effect of irradiation on the meat products and approved the irradiation. In this article, the effectiveness, the international acceptance, the economics and the research trend of irradiation on meat products have been reviewed. Also, the policy plans for the early approval of the irradiated meat products in Korea and the promotion policy of irradiated meats in market were discussed.

  8. Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera

    OpenAIRE

    2015-01-01

    The first commercially approved human gene therapy in the Western world is Glybera (alipogene tiparvovec), which is an adenoassociated viral vector encoding the lipoprotein lipase gene. Glybera was recommended for marketing authorization by the European Medicines Agency in 2012. The European Medicines Agency had only ever reviewed three marketing authorization applications for gene therapy medicinal products. Unlike in the case of Glybera, the applications of the first two products, Cerepro a...

  9. 78 FR 26258 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2013-05-06

    ... conditionally approved four paragraphs of 35 IAC Part 223, noting deficiencies in the state rules. The four..., submittal, IEPA has corrected the deficiencies within the prescribed time frame. We are converting...

  10. 12 CFR 1253.8 - Availability of new product to an Enterprise after it has been approved for the other Enterprise.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Availability of new product to an Enterprise... HOUSING FINANCE AGENCY ENTERPRISES PRIOR APPROVAL FOR ENTERPRISE PRODUCTS § 1253.8 Availability of new... a new product for one Enterprise or the new product is otherwise available to that Enterprise...

  11. PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System Effectiveness For Managing Post-Approval Changes.

    Science.gov (United States)

    Ramnarine, Emma; Busse, Ursula; Chassant, Franck; Colao, Marcello; Edwards, Julia; O'Donnell, Kevin; Jornitz, Maik; Munk, Morten; Seymour, Melissa; Simianu, Mihaela; Skeens, Lisa; Vinther, Anders

    2017-02-14

    The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1). But what exactly constitutes an effective PQS? And how does it support change management for PACs? This paper intends to answer these questions and guide companies to seize the opportunities outlined in ICH Q10-Annex 1, to manage product and process changes within the PQS, and downgrade the level of regulatory submission required. This is the second of a series of PDA "Points to Consider" papers on technical product lifecycle management; the first paper focused on the technical product lifecycle management strategy including communication and knowledge exchange between Marketing Authorization Holders and Health Authorities.

  12. 77 FR 33659 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Consumer Products and...

    Science.gov (United States)

    2012-06-07

    ... more stringent than, EPA's national consumer products and architectural and industrial maintenance (AIM... products and architectural and industrial maintenance coatings at Part 223 of Title 35 of the Illinois... architectural and industrial maintenance coatings. (i) Incorporation by reference. (A) Illinois...

  13. 77 FR 64374 - Notification of Petition for Approval; Port Authority Trans-Hudson Product Safety Plan

    Science.gov (United States)

    2012-10-19

    ... manner and meets the requirements of 49 CFR part 236, subpart H- Standards for Processor-Based Signal and... circuit is part of Alstom's Smartway Digital Track Circuit product line and will be used by PATH for...

  14. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.

    Science.gov (United States)

    Lee, Sau L; Saluja, Bhawana; García-Arieta, Alfredo; Santos, Gustavo Mendes Lima; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

    2015-09-01

    This article describes regulatory approaches for approval of "generic" orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the "original" product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as "generic" and "reference" drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches.

  15. The potential of plants as a system for the development and production of human biologics [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Qiang Chen

    2016-05-01

    Full Text Available The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  16. Bacteriocin production: a relatively unharnessed probiotic trait? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    James W. Hegarty

    2016-10-01

    Full Text Available Probiotics are “live microorganisms which, when consumed in adequate amounts, confer a health benefit to the host”. A number of attributes are highly sought after among these microorganisms, including immunomodulation, epithelial barrier maintenance, competitive exclusion, production of short-chain fatty acids, and bile salt metabolism. Bacteriocin production is also generally regarded as a probiotic trait, but it can be argued that, in contrast to other traits, it is often considered a feature that is desirable, rather than a key probiotic trait. As such, the true potential of these antimicrobials has yet to be realised.

  17. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

    Science.gov (United States)

    Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

    2015-11-01

    The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

  18. 76 FR 66663 - Approval and Promulgation of Implementation Plans; Illinois; Consumer Products and AIM Rules

    Science.gov (United States)

    2011-10-27

    ... limitations for the sale, supply, offered for sale, use, or manufacture for sale of aerosol adhesives, floor wax strippers, products containing ozone-depleting compounds, and charcoal lighter material. (3) Test... review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4,...

  19. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  20. Recent progress and future challenges in algal biofuel production [version 1; referees: 4 approved

    Directory of Open Access Journals (Sweden)

    Jonathan B. Shurin

    2016-10-01

    Full Text Available Modern society is fueled by fossil energy produced millions of years ago by photosynthetic organisms. Cultivating contemporary photosynthetic producers to generate energy and capture carbon from the atmosphere is one potential approach to sustaining society without disrupting the climate. Algae, photosynthetic aquatic microorganisms, are the fastest growing primary producers in the world and can therefore produce more energy with less land, water, and nutrients than terrestrial plant crops. We review recent progress and challenges in developing bioenergy technology based on algae. A variety of high-value products in addition to biofuels can be harvested from algal biomass, and these may be key to developing algal biotechnology and realizing the commercial potential of these organisms. Aspects of algal biology that differentiate them from plants demand an integrative approach based on genetics, cell biology, ecology, and evolution. We call for a systems approach to research on algal biotechnology rooted in understanding their biology, from the level of genes to ecosystems, and integrating perspectives from physical, chemical, and social sciences to solve one of the most critical outstanding technological problems.

  1. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  2. 14 CFR 21.325 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.325... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Export Airworthiness Approvals § 21.325 Export airworthiness approvals. (a) Kinds of approvals. (1) Export airworthiness approval of Class I products is...

  3. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... medicated article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and approved conditions of use for... NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this time, the tolerances for residues of... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 Animal Drugs, Feeds, and...

  4. Heartland Winthrop Approval

    Science.gov (United States)

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  5. Recent advances in the elucidation of enzymatic function in natural product biosynthesis [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Tan Gao-Yi

    2015-12-01

    Full Text Available With the successful production of artemisinic acid in yeast, the promising potential of synthetic biology for natural product biosynthesis is now being realized. The recent total biosynthesis of opioids in microbes is considered to be another landmark in this field. The importance and significance of enzymes in natural product biosynthetic pathways have been re-emphasized by these advancements. Therefore, the characterization and elucidation of enzymatic function in natural product biosynthesis are undoubtedly fundamental for the development of new drugs and the heterologous biosynthesis of active natural products. Here, discoveries regarding enzymatic function in natural product biosynthesis over the past year are briefly reviewed.

  6. Recent advances in the elucidation of enzymatic function in natural product biosynthesis [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Gao-Yi Tan

    2016-02-01

    Full Text Available With the successful production of artemisinic acid in yeast, the promising potential of synthetic biology for natural product biosynthesis is now being realized. The recent total biosynthesis of opioids in microbes is considered to be another landmark in this field. The importance and significance of enzymes in natural product biosynthetic pathways have been re-emphasized by these advancements. Therefore, the characterization and elucidation of enzymatic function in natural product biosynthesis are undoubtedly fundamental for the development of new drugs and the heterologous biosynthesis of active natural products. Here, discoveries regarding enzymatic function in natural product biosynthesis over the past year are briefly reviewed.

  7. 30 CFR 18.81 - Field modification of approved (permissible) equipment; application for approval of modification...

    Science.gov (United States)

    2010-07-01

    ... TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Machines Assembled With Certified or Explosion-Proof Components, Field Modifications of Approved Machines... and Certification Center, 765 Technology Drive, Triadelphia, WV 26059. (b) Proposed...

  8. 78 FR 52430 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

    Science.gov (United States)

    2013-08-23

    ... Animal Drug Applications; Quali- Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin... (pyrantel tartrate), NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC...

  9. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

    Science.gov (United States)

    Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo

    2016-06-01

    In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

  10. 78 FR 52535 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

    Science.gov (United States)

    2013-08-23

    ...; Quali- Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin AGENCY: Food and Drug... feeds, are no longer manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin...

  11. Everolimus: the first approved product for patients with advanced renal cell cancer after sunitinib and/or sorafenib

    Directory of Open Access Journals (Sweden)

    Chris Coppin

    2010-04-01

    Full Text Available Chris CoppinMedical Oncology, BC Cancer Agency and University of British Columbia, Vancouver, CanadaAbstract: Everolimus (RAD001, Afinitor® Novartis is the first oral inhibitor of mTOR (mammalian target of rapamycin to reach the oncology clinic. Everolimus 10 mg daily achieves complete inhibition of its target at below the maximum tolerable dose for most patients. A phase III randomized placebo-controlled trial has examined the impact of everolimus in patients with clear cell renal cancers and progressive disease on or within 6 months of the VEGFR tyrosine kinase inhibitors sunitinib and/or sorafenib. The primary endpoint of progression-free survival was increased from median 1.9 to 4.9 months (hazard ratio 0.33, P < 0.001 and 25% were still progression-free after 10 months of everolimus therapy. There was a delay in time to decline of performance status and trends to improvement in quality of life, disease-related symptoms, and overall survival despite crossover of the majority of patients assigned to placebo. In 2009, everolimus was approved in the US and Europe as the only validated option for this indication. Toxicities are usually mild to moderate and can be managed with dose reduction or interruption if necessary. Opportunistic infections and non-infectious pneumonitis are seen as a class effect. Management of common practical management issues are discussed. Clinical trials are in progress to examine additional roles for everolimus in renal cancer, alone and in combination with other agents.Keywords: everolimus, drug therapy, advanced renal cancer

  12. 30 CFR 35.9 - Certificates of approval.

    Science.gov (United States)

    2010-07-01

    ... APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS General Provisions § 35.9 Certificates of approval. (a) Upon completion of an investigation of a hydraulic fluid MSHA will issue to the applicant... notification of approval will be issued. If a certificate of approval is issued, no test data or...

  13. Approving job profiles for curriculum profiles in health care programs : a study on process and product quality

    NARCIS (Netherlands)

    Mulder, Martin; Engels, Otto

    1992-01-01

    A study evaluated the approach used for validation of job profiles for curriculum development in three health care programs in the Netherlands: dietetics, podotherapy, and activity therapy. It also evaluated the quality of these job profiles and the relation between process and product quality. The

  14. 76 FR 17776 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-31

    ...; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and...., Chaska, MN 55318. G Premix (tylosin phosphate/ sulfamethazine). Abraxis Pharmaceutical Products, Division........ NADA 100-991, McNess Custom 558.625 (010439). Premix L200 (tylosin phosphate). Fort Dodge Animal...

  15. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2011-03-02

    ... Moines, IA 50322. BANMINTH Premix (pyrantel tartrate). Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin... Five NADAs by Truow Nutrition, Inc. NADA No. product 21 CFR section affected (sponsor drug Previous... Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to...

  16. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Science.gov (United States)

    2010-01-01

    ..., the Egg Products Inspection Act, the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and... broken from the shell, shall have a total egg solids content of 24.20 percent or greater. (e) Nutrition... provisions of 21 CFR part 101, promulgated under the Federal Food, Drug, and Cosmetic Act and the...

  17. Confiscated black market products and nutritional supplements with non-approved ingredients analyzed in the Cologne Doping Control Laboratory 2009.

    Science.gov (United States)

    Kohler, Maxie; Thomas, Andreas; Geyer, Hans; Petrou, Michael; Schänzer, Wilhelm; Thevis, Mario

    2010-01-01

    Doping control laboratories are frequently confronted with new substances that may be misused by athletes. Besides new pharmaceuticals, where method development for their detection is dependent on the availability of the substance and corresponding administration studies, some professional and amateur athletes are using illicit 'black market' products, which either differ from known pharmaceuticals but cause similar effects or still are undergoing clinical trials and are therefore rarely available to doping control laboratories. In the Cologne Doping Control Laboratory, different confiscated products and legally obtained nutritional supplements were analyzed in 2009, and various findings were reported including GH-labelled injection vials without any pharmacologically active content; combinations of products indicating the attempt to mask growth hormone abuse; unpurified long-R(3) -IGF-1; nutritional supplements containing the growth hormone releasing peptide-2 (GHRP-2); and ampoules containing the selective androgen receptor modulator Andarine (S-4). This review provides an overview on the substances that were analyzed in 2009. Ingredients relevant for doping control were identified by means of liquid chromatography and mass spectrometry methods. The awareness of new products on the black market and in nutritional supplements is of utmost importance for laboratories to develop detection methods accordingly and screen for new substances as early as possible.

  18. Drugs Approved for Melanoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Melanoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome ( ...

  19. Elosulfase alfa: first global approval.

    Science.gov (United States)

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  20. Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product.

    Science.gov (United States)

    Peinado, Antonio; Hammond, Jonathan; Scott, Andrew

    2011-01-05

    Pharmaceutical companies are progressively adopting and introducing the principles of Quality by Design with the main purpose of assurance and built-in quality throughout the whole manufacturing process. Within this framework, a Partial Least Square (PLS) model, based on Near Infrared (NIR) spectra and humidity determinations, was built in order to determine in-line the drying end point of a fluidized bed process. The in-process method was successfully validated following the principles described within The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH Q2 (r1) - Validation of Analytical Procedures: Text and Methodology. However, in some aspects, the cited guidelines were not appropriate to in-process methods developed and validated exclusively with in-line samples and implemented in dynamic systems, such as drying processes. In this work, a customized interpretation of guidelines has been adopted which provided the framework of evidence to support a validated application. The application has been submitted to the United States Food and Drug Administration (FDA) and The European Medicines Agency (EMA) during applications for grant of licences. Representatives from these Regulatory Authorities have specifically reviewed this novel application during on-site inspections, and have subsequently approved both the product and this application. Currently, the NIR method is implemented as a primary in-line method to control the drying end point in real-time (to below a control limit of not greater than 1.2% w/w) for commercial production batches of an approved, solid, oral-dose medicine. The implementation of this in-process method allows real-time control with benefits including a reduction in operation time and labour; sample handling and waste generation; and a reduced risk to product quality in further unit operations due to improved consistency of intermediate output at this stage. To date

  1. Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares Biological Medicinal Products: Requirements for the Development and Approval of Biosimilars

    Directory of Open Access Journals (Sweden)

    Begoña Calvo

    2010-01-01

    Full Text Available En este artículo se revisan las directrices europeas de comparabilidad que establecen la metodología para la determinación de biosimilitud entre los medicamentos biosimilares (follow-on biologics en USA y el medicamento biológico de referencia. Los biosimilares son medicamentos biológicos parecidos pero no idénticos al medicamento original y pueden ser fabricados por cualquier fabricante al finalizar el periodo de patente de los medicamentos biotecnológicos. En el articulo se detallan las directrices de la Agencia Europea del Medicamento (EMA y de la Conferencia Internacional de Armonización (ICH a tener en cuenta en el desarrollo y aprobación de estos medicamentos. Se demuestra que los medicamentos biosimilares no pueden considerarse medicamentos genéricos, siendo necesario realizar una serie de ensayos adicionales previos a la obtención de la autorización de comercialización.This article reviews the European guidelines on drugs comparability that establish the methodology for verifying biosimilarity between the so-called biosimilar drugs and the reference biological medicinal product. Biosimilars are biological medicines similar but not identical to the original drugs and can be manufactured by any laboratory after the expiration of biotech drugs patent. The guidelines of the European Medicines Agency (EMA and the International Conference on Harmonization (ICH that must be considered in the development and approval of these drugs also are reviewed. It is shown that biosimilars cannot be considered as generic drugs, being necessary to conduct additional assays prior to obtain marketing authorization.

  2. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  3. Post-Approval Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...

  4. Depression: FDA-Approved Medications May Help

    Science.gov (United States)

    ... Products For Consumers Home For Consumers Consumer Updates Depression: FDA-Approved Medications May Help Share Tweet Linkedin ... symptoms in some people. back to top Diagnosing Depression Diagnosis—which should be from a health care ...

  5. 27 CFR 24.26 - Authority to approve.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF THE TREASURY LIQUORS WINE Administrative and Miscellaneous Provisions Authorities § 24.26 Authority to approve. The appropriate TTB officer is authorized to approve, except as otherwise provided in... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Authority to approve....

  6. Trends in global approvals of biotech crops (1992-2014).

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

  7. 27 CFR 27.206 - Bottles not constituting approved containers.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Bottles not constituting approved containers. 27.206 Section 27.206 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX... officer that such bottle is not an approved container for distilled spirits for consumption in the...

  8. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  9. Drugs Approved for Lung Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer drugs approved by the ... listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate (Methotrexate) Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) ...

  10. 40 CFR 152.113 - Approval of registration under FIFRA sec. 3(c)(7)-Products that do not contain a new active...

    Science.gov (United States)

    2010-07-01

    ... sec. 3(c)(7)-Products that do not contain a new active ingredient. 152.113 Section 152.113 Protection... FIFRA sec. 3(c)(7)—Products that do not contain a new active ingredient. (a) Except as provided in... product for a new use under FIFRA sec. 3(c)(7)(B) if: (1) The pesticide is the subject of a special...

  11. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North America,...

  14. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  15. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North...

  16. 7 CFR 319.37-9 - Approved packing material.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved packing material. 319.37-9 Section 319.37-9..., and Other Plant Products 1,2 § 319.37-9 Approved packing material. Any restricted article at the time of importation or offer for importation into the United States shall not be packed in a...

  17. 14 CFR 21.8 - Approval of articles.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Approval of articles. 21.8 Section 21.8 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS General § 21.8 Approval of articles. If an article is required to...

  18. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  19. Pomalidomide: first global approval.

    Science.gov (United States)

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  20. Apremilast: first global approval.

    Science.gov (United States)

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  1. 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.

  2. FHR Iowa Falls Approval

    Science.gov (United States)

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  3. 30 CFR 18.91 - Electric equipment for which field approvals will be issued.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electric equipment for which field approvals... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.91 Electric...

  4. 48 CFR 45.606-1 - Contractor with an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-1 Section 45.606-1 Federal Acquisition Regulations System FEDERAL... Contractor with an approved scrap procedure. (a) The contractor may dispose of scrap resulting from production or testing under this contract without Government approval. However, if the scrap...

  5. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  6. Pitolisant: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  7. Baricitinib: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  8. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  9. 78 FR 66748 - Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval of 14 New Drug Applications...

    Science.gov (United States)

    2013-11-06

    ... Approval of 14 New Drug Applications; Opportunity for a Hearing AGENCY: Food and Drug Administration, HHS... hearing on the Agency's proposal to withdraw approval of 14 new drug applications (NDAs) from multiple... to remove the products from the market. Any new drug product marketed without an approved new...

  10. 78 FR 66826 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2013-11-07

    ... submitted for evaluation and approval before use under the final rule are: (1) Labels for chicken produced..., such as ``no antibiotics administered'' or ``vegetarian fed''; (4) instructional or...

  11. 77 FR 16544 - Pesticide Product Registration Approvals

    Science.gov (United States)

    2012-03-21

    ... Number: EPA-HQ-OPP-2010-0023. a. Description of New Active Ingredient: Monsanto Company submitted an.... Monsanto Company noted several technical corrections needed to be made to the proposed decision and risk... participation. Monsanto also requested a longer expiration date (five vs. two years) for its registration....

  12. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  13. Obinutuzumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  14. Safinamide: first global approval.

    Science.gov (United States)

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  15. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    ... Human Papillomavirus (HPV) Nonavalent Vaccine Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine Drugs Approved to Treat Cervical Cancer Avastin (Bevacizumab) Bevacizumab Blenoxane (Bleomycin) Bleomycin Hycamtin (Topotecan ...

  16. Approval times and the safety of new pharmaceuticals.

    Science.gov (United States)

    Rudholm, Niklas

    2004-12-01

    This study examined the relationship between the approval times for new pharmaceuticals and the number of adverse drug reactions reported to the Swedish Medical Products Agency. Yearly time-series data concerning the number of adverse drug reactions, as well as data concerning prices and quantities sold for 25 pharmaceutical substances during the period 1972-1996 were used. The results show that shorter approval times are associated with more adverse drug reactions, but also that the effects are quite small.

  17. Adapting drug approval pathways for bacteriophage-based therapeutics

    Directory of Open Access Journals (Sweden)

    Callum Cooper

    2016-08-01

    Full Text Available The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i phages possess different biological, physical and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics / pharmacokinetics. (ii The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and Right to try legislation.

  18. Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

    Directory of Open Access Journals (Sweden)

    Chia-Wei eTsai

    2015-12-01

    Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

  19. FDA-Approved HIV Medicines

    Science.gov (United States)

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...

  20. 76 FR 55842 - Partial Approval and Partial Disapproval of Air Quality Implementation Plans; California; San...

    Science.gov (United States)

    2011-09-09

    ... October 2011. 2. Rule 4401--Steam Enhanced Crude Oil Production Wells--final limited approval/disapproval January 26, 2010 (75 FR 3996). Amendments submitted to EPA on July 28, 2011. 3. Rule 4402--Crude Oil Production Sumps--final limited approval/ disapproval July 7, 2011 (76 FR 39777). District...

  1. 7 CFR 58.50 - Approval and form of official identification.

    Science.gov (United States)

    2010-01-01

    ... Dairy Products Marking, Branding, and Identifying Product § 58.50 Approval and form of official... in a shield in the form and design indicated in Figures 1, 2, and 3 of this section or such other form, design, or wording as may be approved by the Administrator. EC25SE91.014 EC25SE91.015...

  2. 9 CFR 147.48 - Approval of conference recommendations by the Department.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of conference recommendations by the Department. 147.48 Section 147.48 Animals and Animal Products ANIMAL AND PLANT HEALTH... Department for incorporation into the provisions of the NPIP. The Department reserves the right to approve...

  3. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2004-01-01

    With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

  4. 27 CFR 4.91 - List of approved prime names.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false List of approved prime names. 4.91 Section 4.91 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... Muscat Grand Noir Green Hungarian Grenache Grignolino Grillo Gros Verdot Helena Herbemont Higgins...

  5. 49 CFR 236.913 - Filing and approval of PSPs.

    Science.gov (United States)

    2010-10-01

    ... for Processor-Based Signal and Train Control Systems § 236.913 Filing and approval of PSPs. (a) Under... architectural concepts; the PSP describes a product that uses design or safety assurance concepts considered... the end of the system design review phase of product development and 180 days prior to...

  6. 9 CFR 355.34 - Labels, approval of, by Administrator.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labels, approval of, by Administrator. 355.34 Section 355.34 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF... be a complete reproduction of the label as it will appear on the package, including any color...

  7. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Types of respirators to be approved; scope of... Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.50 Types of respirators to be approved; scope of approval. Approvals shall be issued for the types of respirators...

  8. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    ... about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel Doxorubicin Hydrochloride 5-FU (Fluorouracil ...

  9. 48 CFR 252.227-7024 - Notice and approval of restricted designs.

    Science.gov (United States)

    2010-10-01

    ... structures, machines, products, materials, construction methods, and equipment that are readily available through Government or competitive commercial channels, or through standard or proven production techniques, methods, and processes. Unless approved by the Contracting Officer, the Contractor shall not produce...

  10. Approval plans issues and innovations

    CERN Document Server

    Katz, Linda S

    2013-01-01

    How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

  11. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  15. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  17. Is It Really FDA Approved?

    Science.gov (United States)

    ... does not approve cosmetics. Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body ... and provide the agency with a notification before marketing a new formula. FDA conducts yearly inspections of ...

  18. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

    US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

  19. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  20. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Breast Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  4. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for prostate cancer. The list includes generic ...

  6. Trulance Approved for Chronic Constipation

    Science.gov (United States)

    ... news/fullstory_163171.html Trulance Approved for Chronic Constipation Drug designed to stimulate upper gastrointestinal tract To ... U.S. Food and Drug Administration to treat persistent constipation of unknown (idiopathic) cause in adults. Some 42 ...

  7. Pesticide Product Label System

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Pesticide Product Label System (PPLS) provides a collection of pesticide product labels (Adobe PDF format) that have been approved by EPA under Section 3 of the...

  8. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area.

  9. 77 FR 50702 - Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications

    Science.gov (United States)

    2012-08-22

    ... Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications... introduction into interstate commerce of products without approved new drug applications violates section...

  10. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a biological product for which safety has... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  11. 21 CFR 515.20 - Approval of medicated feed mill license applications.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Approval of medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.20 Approval of medicated feed mill license applications. Within 90 days after...

  12. 21 CFR 515.21 - Refusal to approve a medicated feed mill license application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Refusal to approve a medicated feed mill license... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.21 Refusal to approve a medicated feed mill license application. (a)...

  13. 14 CFR 21.500 - Approval of engines and propellers.

    Science.gov (United States)

    2010-01-01

    ... AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Engines, Propellers, Materials, Parts.... type certificate for an aircraft engine or propeller manufactured in a foreign country with which the... with each such aircraft engine or propeller imported into this country, a certificate of...

  14. FDA Approvals of Brand-Name Prescription Drugs in 2015.

    Science.gov (United States)

    2016-03-01

    The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories: New Pharmaceuticals: New Molecular Entities and New Biologic License ApplicationsNew Combinations and New IndicationsNew Dosage Forms and New FormulationsNew Biosimilars, Vaccines, Viral Therapies, and Blood Products.

  15. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

    With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

  16. 77 FR 8865 - Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval

    Science.gov (United States)

    2012-02-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval... State of Illinois submitted a primacy application for its approved Public Water System...

  17. / production

    Indian Academy of Sciences (India)

    François Arleo; Pol-Bernard Gossiaux; Thierry Gousset; Jörg Aichelin

    2003-04-01

    For more than 25 years /Ψ production has helped to sharpen our understanding of QCD. In proton induced reaction some observations are rather well understood while others are still unclear. The current status of the theory of /Ψ production will be sketched, paying special attention to the issues of formation time and /Ψ re-interaction in a nuclear medium.

  18. Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseases.

    Science.gov (United States)

    Xu, Kui; Coté, Timothy R

    2011-07-01

    Facing substantial obstacles to developing new therapies for rare diseases, some sponsors are looking to 'repurpose' drugs already approved for other conditions and use those therapies to treat rare diseases. In an effort to facilitate such repurposing and speed the delivery of new therapies to people who need them, we have established a new resource, the Rare Disease Repurposing Database (RDRD). The advantages of repurposed compounds include their demonstrated efficacy (in some clinical contexts), their observed toxicity profiles and their clearly described manufacturing controls. To create the RDRD, we matched the US Food and Drug Administration (FDA) orphan designation database to FDA drug and biological product approval lists. The RDRD lists 236 products that have received orphan status designation--that is, were found to be 'promising' for the treatment of a rare disease--and though not yet approved for marketing for that rare disease, they are already approved for marketing to treat some other disease or condition. The RDRD contains three tables: Orphan-designated products with at least one marketing approval for a common disease indication (N = 109); orphan-designated products with at least one marketing approval for a rare disease indication (N = 76); and orphan-designated products with marketing approvals for both common and rare disease indications (N = 51). While the data included in the database is a re-configuration/cross-indexing of information already released by the FDA, it offers sponsors a new tool for finding special opportunities to develop niche therapies for rare disease patients.

  19. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  20. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  2. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

    @@ The feasibility study on alkylbenzene project in Dushanzi, Xinjiang Uygur Autonomous Region, submitted jointly by the government of Xinjiang UygurAutonomous Region and China National Petroleum Corporation (CNPC), has been approved by State Council recently,after pass appraisa l by China International Engineering Consulting Corporation entrusted by State Planning Committee.

  3. Biosimilar agents in oncology/haematology: from approval to practice

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-01-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products. PMID:21175852

  4. Biosimilar agents in oncology/haematology: from approval to practice.

    Science.gov (United States)

    Niederwieser, Dietger; Schmitz, Stephan

    2011-04-01

    The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors have received marketing approval in Europe. This review considers general issues surrounding the introduction of biosimilars and highlights current specific issues pertinent to their use in clinical practice in oncology. Information on marketing approval, extrapolation, labelling, substitution, immunogenicity and traceability of each biosimilar product is important, especially in oncology where patients are treated in repeated therapy courses, often with complicated protocols, and where biosimilars are not used as a unique therapy for replacement of e.g. growth hormone or insulin. While future developments in the regulation of biosimilars will need to address multiple issues, in the interim physicians should remain aware of the inherent differences between biosimilar and innovator products.

  5. 76 FR 70108 - Notice of Intent To Request Approval To Revise and Extend an Information Collection

    Science.gov (United States)

    2011-11-10

    ..., manufactured dry milk, and manufactured whey products. Milk production and manufactured dairy products... currently approved information collection, the Milk and Milk Products Surveys. Revision to burden hours will... Statistics Service, U.S. Department of Agriculture, (202) 720-4333. SUPPLEMENTARY INFORMATION: Title:...

  6. 78 FR 6829 - Approval of AmSpec Services, LLC, as a Commercial Gauger

    Science.gov (United States)

    2013-01-31

    ...Notice is hereby given, pursuant to CBP regulation, that AmSpec Services, LLC, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of August 7,...

  7. 76 FR 64962 - Accreditation and Approval of Intertek USA, Inc., as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2011-10-19

    ... Pintail St., St. Rose, LA 70087, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions...

  8. 77 FR 12866 - Accreditation and Approval of Amspec Services LLC, as a Commercial Gauger and Laboratory

    Science.gov (United States)

    2012-03-02

    ... Services LLC, 12154 B River Road, St. Rose, LA 70087, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in...

  9. 77 FR 12868 - Approval of Saybolt LP, as a Commercial Gauger

    Science.gov (United States)

    2012-03-02

    ..., 190 James Drive East, Suite 110, St. Rose, LA 70087, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions...

  10. 75 FR 53371 - Liquefied Natural Gas Facilities: Obtaining Approval of Alternative Vapor-Gas Dispersion Models

    Science.gov (United States)

    2010-08-31

    ... Pipeline and Hazardous Materials Safety Administration Liquefied Natural Gas Facilities: Obtaining Approval... Safety Administration (PHMSA) issues federal safety standards for siting liquefied natural gas (LNG...) NFPA 59A: Standard for the Production, Storage, and Handling of Liquefied Natural Gas. That...

  11. Establishment of Master Cell Stock and Working Cell Bank of MDCK Lines and Selection and Evaluation of the Lines as Candidate Viral Substrates for Approval Production of Combinational Canine Attenuated-live Virus Vaccines

    Institute of Scientific and Technical Information of China (English)

    ZHANG De-li; FANG Fu-de; LI Liu-jin; XIA Geng-tian; HE Xu-yu; GAO Bu-xian; BAI Xiao-hong; HUANG Gao-sheng; LIU Shang-gao; YEN Lung-fei

    2002-01-01

    Under the prerequisite that the incidence of cancer or tumor in negative-control nude mice inoculated subcutaneously with primary feline or canine kidney cell cultures purified in vitro at passage 3 was 0(0/22) and 0 (0/10), respectively. The incidence of the progressively-growing malignant tumor(MT) in positive-control nude mice inoculated subcutaneously with Hela cell cultures of KB, X, or NM20/X strain was 10/10, 25/25 and 5/51, respectively. The results showed that the incidence of tumor in nude mice with di-and hyperploid YB strain of MDCK cell during 17 - 23 passages, with hyper- and hypoploid KA strain of MDCK cell during 6 - 8 passages, with hypoploid WB strain of MDCK cell on passage 6, with hyper-and hypopioid H strain of MDCK cell during 8 - 24 passages was 2/24, 6/10, 5/10 and 10/15, respectively. The chromosomal analysis results showed that the ratio of difference in the rate of modal chromosome number between high(mcs + n) and lowest (mcs)passages was not more than 5- 15% and the structure aberrations was generally 0-3%. These results proved that the genetic characteristics of chromosomal number of cell lines determines their tumorigenicity, but it is species-specific. MDCK line has tumorigenicity no matter what its chromosome karyotype is, at least it has very low tumorigenicity even when its modal chromosome number is hypoploid. It is thus evident that MDCK cell of WB or H strain can be approved as substrate for the preparation of attenuated viral vaccines, but MDCK cell of YB or KA strain can not be approved as substrate for the preparation of attenuated viral vaccines.

  12. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Suspension approval. 552.77 Section 552.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY MILITARY RESERVATIONS AND....77 Suspension approval. The installation commander will personally approve all cases in...

  13. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process...

  14. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process....

  15. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...

  16. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

    Science.gov (United States)

    Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

    2015-01-01

    Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

  17. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    <正>Following Guangdong,Guangxi,Fujian and Jiangxi,Hunan announced that it would consolidate its rare earth resources-the consolidation plan of Hunan Rare Earth Group has been approved. Consolidation of the rare earth industry of south China is in full swing.According to "Several Opinions of the State Council on Promoting the Sustainable and Healthy Development of Rare Earth Industry"(hereinafter referred to as "Several Opinions")released in 2011,

  18. Nelfinavir: fourth protease inhibitor approved.

    Science.gov (United States)

    1997-01-01

    The Food and Drug Administration (FDA) has granted accelerated approval to nelfinavir in both adult and pediatric formulations. Agouron, the manufacturer, used innovative computerized drug design techniques to discover, design, and refine the nelfinavir molecule. Nelfinavir is marketed under the trade name Viracept, and costs $5,000 per year. Early clinical trials find it to be as powerful as the other protease inhibitors, but with a different resistance profile. The drug has relatively few drug indications; however, several compounds have been contraindicated.

  19. 78 FR 55237 - Notice of a Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-10

    ... importer, manufacturer or exporter of certain dairy products; (2) certify they meet the eligibility... and non-cheese dairy products, and exporters of non-cheese dairy products. Estimated Number of... intention to request an extension for a currently approved information collection in support of the...

  20. ELECTRONIC COMPLIANCE AND APPROVAL PROJECT (ECAP)

    Energy Technology Data Exchange (ETDEWEB)

    Hope Morgan; Richard A. Varela; Deborah LaHood; Susan Cisco; Mary Ann Benavides; Donna Burks

    2002-11-01

    The Texas Railroad Commission (RRC), working in partnership with the United States Department of Energy and the oil and gas industry it regulates, is implementing a strategy for improving efficiency in regulations and significantly reducing administrative operating costs through the Electronic Compliance and Approval Process (ECAP). The project will streamline regulatory compliance and reporting by providing the ability to electronically submit, process, and query oil and gas applications and reports through the Internet-based ECAP system. Implementation of an ECAP drilling permit pilot project began September 1999 after funding resources were secured--a $700,000 grant from the U.S. Department of Energy and an appropriation of $1.4 million from the Texas Legislature. The pilot project involves creating the ability to file, review, and approve a well's drilling permit application through a completely electronic process. The pilot project solution will ultimately provide the infrastructure, technology, and electronic modules to enable the filing of all compliance permits and performance reports through the internet from a desktop computer. The pilot project was conducted in three phases. The first phase, implemented May 2000, provided the infrastructure that allows the electronic filing and approval of simple drilling permit applications, associated fees, and attachments. The official ''roll-out'' of ECAP and the first electronically filed drilling permit application occurred on May 11, 2000 in Dallas in conjunction with an Internet Workshop sponsored by the Petroleum Technology Transfer Council. After the completion of Phase I, the ECAP team conducted an extensive review of progress to date and analyzed requirements and opportunities for future steps. The technical team identified core infrastructure modifications that would facilitate and better support future development and expansion of the ECAP system and work began on database structure

  1. 9 CFR 316.5 - Branding ink; to be furnished by official establishments; approval by Program; color.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Branding ink; to be furnished by... THEIR CONTAINERS § 316.5 Branding ink; to be furnished by official establishments; approval by Program... provided in paragraphs (b) and (c) of this section, branding ink of any color, approved for the purpose...

  2. 76 FR 78530 - Applications for Food and Drug Administration Approval To Market a New Drug; Revision of...

    Science.gov (United States)

    2011-12-19

    ... Administration Approval To Market a New Drug; Revision of Postmarketing Reporting Requirements-- Discontinuance... concern that, although the Orange Book lists all drug products with approved new drug applications (NDA) and abbreviated new drug applications (ANDA), it is not possible to determine whether the...

  3. 30 CFR 35.4 - Types of hydraulic fluid for which certificates of approval may be granted.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Types of hydraulic fluid for which certificates..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS FIRE-RESISTANT HYDRAULIC FLUIDS General Provisions § 35.4 Types of hydraulic fluid for which certificates of approval may be...

  4. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Science.gov (United States)

    2013-02-04

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  5. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

    Ishida, Junichi; Konishi, Masaaki; Ebner, Nicole; Springer, Jochen

    2016-09-20

    Research and development of new drugs requires both long time and high costs, whereas safety and tolerability profiles make the success rate of approval very low. Drug repurposing, applying known drugs and compounds to new indications, has been noted recently as a cost-effective and time-unconsuming way in developing new drugs, because they have already been proven safe in humans. In this review, we discuss drug repurposing of approved cardiovascular drugs, such as aspirin, beta-blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, cardiac glycosides and statins. Regarding anti-tumor activities of these agents, a number of experimental studies have demonstrated promising pleiotropic properties, whereas all clinical trials have not shown expected results. In pathological conditions other than cancer, repurposing of cardiovascular drugs is also expanding. Numerous experimental studies have reported possibilities of drug repurposing in this field and some of them have been tried for new indications ('bench to bedside'), while unexpected results of clinical studies have given hints for drug repurposing and some unknown mechanisms of action have been demonstrated by experimental studies ('bedside to bench'). The future perspective of experimental and clinical studies using cardiovascular drugs are also discussed.

  6. OMB Recommended vs Approved Operating Budget

    Data.gov (United States)

    Montgomery County of Maryland — This dataset includes the Fiscal Year 2015 County Executive Recommended and County Council Approved operating budgets for Montgomery County, for comparison purposes....

  7. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  8. 40 CFR 52.1323 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.1323 Section 52.1323 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED... on January 16, 1979 (44 FR 3274) are met. (b) The Administrator approves Rule 10 CSR 10-2.290...

  9. Obinutuzumab breaks through to FDA approval.

    Science.gov (United States)

    2014-01-01

    The U.S. Food and Drug Administration approved the monoclonal antibody obinutuzumab for use with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The drug is the first to receive approval under the agency's breakthrough therapy designation, created in July 2012.

  10. 46 CFR 154.1005 - Equipment approval.

    Science.gov (United States)

    2010-10-01

    ... carried. (b) Each submerged cargo pump motor installation must be specially approved by the Commandant (CG... FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Electrical § 154.1005 Equipment approval. (a) Electrical equipment that is required to be intrinsically safe...

  11. 24 CFR 214.103 - Approval criteria.

    Science.gov (United States)

    2010-04-01

    ... counseling staff must possess a working knowledge of HUD's housing and single-family mortgage insurance... COUNSELING PROGRAM Approval and Disapproval of Housing Counseling Agencies § 214.103 Approval criteria. The... counseling agencies, branches, and affiliates that are included in one application: (a) Nonprofit and...

  12. 38 CFR 21.7220 - Course approval.

    Science.gov (United States)

    2010-07-01

    ...; Pub. L. 98-525) (b) Course approval criteria. In administering benefits payable under 38 U.S.C.... (1) Section 21.4250 (except paragraph (c)(1))—Jurisdiction for course and licensing and certification... study; and (12) Section 21.4268—Approval of licensing and certification tests. (Authority: 38...

  13. QbD implementation and Post Approval Lifecycle Management (PALM).

    Science.gov (United States)

    Ohage, Ettore; Iverson, Raquel; Krummen, Lynne; Taticek, Ron; Vega, Maria

    2016-09-01

    Quality by design (QbD) is a global regulatory initiative with the goal of enhancing pharmaceutical development through the proactive design of pharmaceutical manufacturing process and controls to consistently deliver the intended performance of the product. The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1-3]. An integrated set of risk assessments and their related elements developed at Roche/Genentech were designed to provide an overview of product and process knowledge for the production of a recombinant monoclonal antibody. This chapter describes concepts for implementing the control strategy for a monoclonal antibody including a Design Space for routine commercial manufacturing, and the Post Approval Lifecycle Management (PALM) plan that is used to manage any remaining risks during the commercial lifecycle. The PALM plan is part of the submitted dossier in the regional section and serves as a regulatory agreement between the manufacturer and the health authority specifying how process and product attributes are monitored to ensure both remain within a controlled state post-approval, process parameter changes are managed within the design space, and the control system is updated as necessary based on further process and product knowledge.

  14. 14 CFR 21.502 - Approval of materials, parts, and appliances.

    Science.gov (United States)

    2010-01-01

    ... TRANSPORTATION AIRCRAFT CERTIFICATION PROCEDURES FOR PRODUCTS AND PARTS Approval of Engines, Propellers..., Propellers, and Articles for Import § 21.500 Acceptance of aircraft engines and propellers. An aircraft... product furnishes with each such aircraft engine or propeller imported into the United States, an...

  15. 78 FR 4828 - Notice of Request for Extension of a Currently Approved Information Collection; Importation and...

    Science.gov (United States)

    2013-01-23

    ... due to expire on March 31, 2013. Unless accounted for in an establishment's HACCP plan, meat and... Approved Information Collection; Importation and Transportation of Meat and Poultry Products AGENCY: Food... information collection regarding the importation and transportation of meat and poultry products....

  16. 27 CFR 12.31 - List of approved names by country.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false List of approved names by country. 12.31 Section 12.31 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... Katz. (b) France: Aloxe-Corton, Alsace or Vin d'Alsace, Anjou, Barsac, Batard-Montrachet,...

  17. Research and development on Safety Production Assessment List Examination and Approval System of Urban Transit based on workflow%基于工作流的城市轨道交通安全生产考核表单流转审批系统研发

    Institute of Scientific and Technical Information of China (English)

    秦健; 李军; 钱进; 牛宏睿; 白丽

    2012-01-01

    In order to reduce the difficulty of the development for the process of complex list examination and approval, improve the management efficiency of the application system, it was proposed the Safety Production Assessment List Examination and Approval System of Urban Transit based on the workflow technology. The System could be flexible to meet the changes of the workflow. The process administrator could process intervention when it was needed. According to the reference model of the workflow, the process definition of the workflow, the exchange interface, the application interface of the workflow client, as well as the system management and monitoring interface were implemented. The System consisted of three parts of process definition, process execution control and process monitoring, provided list design, process steps and flow definition to support complex process, could meet the diversified needs of the rail transit safety production business process of Urban Transit.%为了降低复杂表单审批流程的开发难度,提高应用系统的管理效率,本文提出基于工作流技术的城市轨道交通安全生产考核表单流转审批系统.系统能够满足工作流程的变更,并在管理员需要时可以进行流程干预.依据工作流参考模型,实现工作流过程定义、交换接口、工作流客户应用程序接口、系统管理和监控接口,系统由流程定义、流程执行控制和流程监控3部分组成,提供表单设计、流程步骤及流转定义,支持复杂流程,可满足轨道交通安全生产业务流程多样化的需要.

  18. Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar.

    Science.gov (United States)

    Agarwal, Amit B; McBride, Ali

    2016-08-01

    The World Health Organization defines a biosimilar as "a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product." Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. Approval requires a comparability exercise consisting of extensive analytical and preclinical in vitro and in vivo studies, and confirmatory clinical studies. Extrapolation of biosimilars from their original indication to another is a feasible but highly stringent process reliant on rigorous scientific justification. This review focuses on the processes involved in gaining biosimilar approval and extrapolation and details the comparability exercise undertaken in the European Union between originator erythropoietin-stimulating agent, Eprex(®), and biosimilar, Retacrit™.

  19. Video Production with Fewer Errors.

    Science.gov (United States)

    Veilleux, Rene G.

    1991-01-01

    Ten steps to avoid postproduction video revision are needs analysis; use of production, review, and management teams; demonstration for the scriptwriter; script approval; rehearsal; revision; final taping; editing; and final review. (SK)

  20. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  1. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gestational trophoblastic disease. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  2. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  3. FDA Approves First Immunotherapy for Lymphoma

    Science.gov (United States)

    The FDA has approved nivolumab (Opdivo®) for the treatment of patients with classical Hodgkin lymphoma whose disease has relapsed or worsened after receiving an autologous hematopoietic stem cell transplantation followed by brentuximab vedotin (Adcetris®)

  4. 30 CFR 7.409 - Approval marking.

    Science.gov (United States)

    2010-07-01

    ... approval number in addition to the number and size (gauge) of conductors and cable type. For cables containing electric conductors, the marking shall also include the voltage rating. For splices, the...

  5. Drugs Approved for Kidney (Renal Cell) Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for kidney (renal cell) cancer. The list ...

  6. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes ...

  7. Drugs Approved for Non-Hodgkin Lymphoma

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural Media ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for non-Hodgkin lymphoma. The list includes ...

  8. Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

    Science.gov (United States)

    Ning, Yang-Min; Maher, V Ellen

    2015-03-01

    Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 new urologic oncology products in the last 2 decades. Despite these advances, more effective treatments need to be developed and approved for the treatment of urologic malignancies. This review provides general information about the FDA's role in the development of investigational new drugs, with an emphasis on the regulatory process and the requirements for marketing approval. In addition, this review summarizes the products for the treatment of urologic malignancies that were approved by the FDA in the last 30 years and the key issues concerning urologic oncology products that were discussed publicly at Oncologic Drug Advisory Committee meetings in the past 10 years.

  9. ANSI / FM Approvals 2510 flood abatement equipment test standard

    Directory of Open Access Journals (Sweden)

    Kravetz Frédéric

    2016-01-01

    Full Text Available Natural hazards, including flooding, continue to be the leading cause of commercial and industrial property damage worldwide. Until recently, there has been a limited amount of readily available guidance on choosing flood abatement protection. FM Approvals, a division of FM Global, one of the world’s largest business property insurers, working together with the Association of State Floodplain Managers and the US Army Corps of Engineers have developed a National Flood Barrier Test Program after recognizing the urgent demand for reliable flood abatement products to mitigate potential losses. This lead to the ANSI/ FM2510 flood abatement equipment standard.

  10. 76 FR 75809 - Prior Label Approval System: Generic Label Approval

    Science.gov (United States)

    2011-12-05

    ... Food Standards and Labeling Policy Book; does not bear any special claims, such as quality claims... addition, deletion, or amendment of recipe suggestions for the product; j. Any change in punctuation; k... Policy Book, and questions and answers on various topics, such as irradiation and the labeling...

  11. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Science.gov (United States)

    2011-06-17

    ... Enforcement Policy for Over-the- Counter Sunscreen Drug Products Marketed Without an Approved Application... ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance... enforcement policy for certain OTC sunscreen products marketed without an approved new drug application....

  12. 76 FR 22359 - Notice of Request for Extension of Approval of an Information Collection; Importation of Poultry...

    Science.gov (United States)

    2011-04-21

    ... Approval of an Information Collection; Importation of Poultry Meat and Other Poultry Products From Sinaloa... importation of poultry meat and other poultry products from Sinaloa and Sonora, Mexico. DATES: We will... poultry meat and other poultry products from Sinaloa and Sonora, Mexico, contact Dr. Magde Elshafie,...

  13. 36 CFR 28.15 - Approval of local zoning ordinances.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Approval of local zoning... INTERIOR FIRE ISLAND NATIONAL SEASHORE: ZONING STANDARDS Federal Standards and Approval of Local Ordinances § 28.15 Approval of local zoning ordinances. (a) The Secretary shall approve local ordinances...

  14. Natural rates of teacher approval and disapproval in the classroom.

    Science.gov (United States)

    White, M A

    1975-01-01

    Sixteen classroom observational studies were conducted to determine natural rates of teacher verbal approval and disapproval in the classroom. Rates of teacher verbal approval and disapproval were measured by the Teacher Approval and Disapproval Observation Record (TAD) over Grades 1 through 12. Teacher verbal approval rates dropped over grade, with a marked drop after second grade. In every grade after second, the rate of teacher verbal disapproval exceeded the rate of teacher verbal approval. These rates are interpreted in terms of reinforcement theory.

  15. 46 CFR 160.024-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ...) Chromaticity. The color of the burning signal must be vivid red as defined by Sections 13 and 14 of the “Color... from an incandescent lamp operated at a color temperature close to 2,848° K at a distance of about 30... accurate determinations of chromaticity in terms of the 1931 CIE Standard Observer and Coordinate...

  16. 46 CFR 160.036-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ...) Chromaticity. The color of the burning signal must be vivid red as defined by Sections 13 and 14 of the “Color... from an incandescent lamp operated at a color temperature close to 2,848° K at a distance of about 30... accurate determinations of chromaticity in terms of the 1931 CIE Standard Observer and Coordinate...

  17. 77 FR 10515 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2012-02-22

    ... preservative additive used to treat fibers. List of Subjects Environmental protection, Chemicals, Pests and... used as an antimicrobial and preservative additive used to treat fibers, plastics, polymers, latex... producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but...

  18. 75 FR 52737 - Pesticide Product Registrations; Unconditional and Conditional Approvals

    Science.gov (United States)

    2010-08-27

    ... soilless potting media and compost in nurseries and greenhouses, for potting seeds and seedlings of... potting media and compost in nurseries and greenhouses, for potting seeds and seedlings of ornamentals...

  19. 46 CFR 160.022-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ..., the signals in the lot may be reworked by the manufacturer to correct the problem. Samples from the... unshadowed portions of the smoke with a color chart held so as to receive the same daylight illumination...

  20. 46 CFR 160.037-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... by the manufacturer to correct the problem. Samples from the rejected lot must be retested in order... illumination as the unshadowed portions of the smoke. The color of the smoke must be orange as defined...

  1. 46 CFR 160.057-4 - Approval and production tests.

    Science.gov (United States)

    2010-10-01

    ... in the lot may be reworked by the manufacturer to correct the problem. Samples from the rejected lot... illumination as the unshadowed portions of the smoke. The color of the smoke must be orange as defined...

  2. 12 CFR 1253.4 - New product approval.

    Science.gov (United States)

    2010-01-01

    ..., regulation, or FHFA policy thereunder, or contrary to public interest or the safety and soundness of the... applicable statutory and regulatory standards, FHFA policies, public interest, or the safety and soundness of... policies, public interest, and the safety and soundness of the Enterprise or the mortgage finance...

  3. 75 FR 57019 - Pesticide Product Registrations; Conditional Approval

    Science.gov (United States)

    2010-09-17

    ... leaf spot, leaf spot, powdery mildew, and soybean rust, and on apples to control cedar apple rust, powdery mildew, quince rust, and scab. List of Subjects Environmental protection, Chemicals, Pests...

  4. Enzymes approved for human therapy: indications, mechanisms and adverse effects.

    Science.gov (United States)

    Baldo, Brian A

    2015-02-01

    Research and drug developments fostered under orphan drug product development programs have greatly assisted the introduction of efficient and safe enzyme-based therapies for a range of rare disorders. The introduction and regulatory approval of 20 different recombinant enzymes has enabled, often for the first time, effective enzyme-replacement therapy for some lysosomal storage disorders, including Gaucher (imiglucerase, taliglucerase, and velaglucerase), Fabry (agalsidase alfa and beta), and Pompe (alglucosidase alfa) diseases and mucopolysaccharidoses I (laronidase), II (idursulfase), IVA (elosulfase), and VI (galsulfase). Approved recombinant enzymes are also now used as therapy for myocardial infarction (alteplase, reteplase, and tenecteplase), cystic fibrosis (dornase alfa), chronic gout (pegloticase), tumor lysis syndrome (rasburicase), leukemia (L-asparaginase), some collagen-based disorders such as Dupuytren's contracture (collagenase), severe combined immunodeficiency disease (pegademase bovine), detoxification of methotrexate (glucarpidase), and vitreomacular adhesion (ocriplasmin). The development of these efficacious and safe enzyme-based therapies has occurred hand in hand with some remarkable advances in the preparation of the often specifically designed recombinant enzymes; the manufacturing expertise necessary for commercial production; our understanding of underlying mechanisms operative in the different diseases; and the mechanisms of action of the relevant recombinant enzymes. Together with information on these mechanisms, safety findings recorded so far on the various adverse events and problems of immunogenicity of the recombinant enzymes used for therapy are presented.

  5. 78 FR 40090 - Notice of Request for Revision of a Currently Approved Information Collection (Interstate...

    Science.gov (United States)

    2013-07-03

    ..., national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or... the ability to type short comments directly into the comment field on this Web page or attach a file... Products. Type of Request: Revision of an approved information collection. OMB Control Number:...

  6. 77 FR 38269 - Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 7M; Amgen Manufacturing...

    Science.gov (United States)

    2012-06-27

    ... Foreign-Trade Zones Board Approval for Expanded Manufacturing Authority; Foreign-Trade Subzone 7M; Amgen Manufacturing Limited (Biotechnology and Healthcare Products); Juncos, Puerto Rico Pursuant to its authority... Company, grantee of FTZ 7, has requested an expansion of the scope of manufacturing authority on behalf...

  7. 78 FR 73238 - Currently Approved Information Collection: Comment Request for Customer Satisfaction and Opinion...

    Science.gov (United States)

    2013-12-05

    ... United States Mint Currently Approved Information Collection: Comment Request for Customer Satisfaction... United States Mint customer satisfaction and opinion surveys and focus group interviews. DATES: Written... States Mint products, and to determine the level of satisfaction of United States Mint customers and...

  8. 78 FR 23545 - Proposed Extension of Approval of Information Collection; Comment Request: Third Party Conformity...

    Science.gov (United States)

    2013-04-19

    ... COMMISSION Proposed Extension of Approval of Information Collection; Comment Request: Third Party Conformity... collection regarding a form used to evaluate whether third party conformity assessment bodies meet the requirements to test for compliance to specified children's product safety rules. Third party...

  9. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Science.gov (United States)

    2010-04-01

    ... the new animal drug (or abstracts of them) including clinical trials on safety and effectiveness... approved new animal drugs. 514.80 Section 514.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL...

  10. 78 FR 78716 - Withdrawal of Approval of New Animal Drug Applications; Roxarsone

    Science.gov (United States)

    2013-12-27

    ... Applications; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and... five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's... requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form...

  11. 77 FR 34027 - Proposed Extension of Approval of Information Collection; Comment Request-Testing and...

    Science.gov (United States)

    2012-06-08

    ... years from the date of approval by the Office of Management and Budget (OMB), of information collection... to perform each year varies, depending upon the number of carpet styles and the annual volume of... may vary from one to 200, depending upon the number of carpet styles and the annual production...

  12. 78 FR 30843 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2013-05-23

    ... agricultural products and to encourage research and innovation aimed at improving the efficiency and... and innovation aimed at improving the efficiency and performance of the U.S. marketing system... Agricultural Marketing Service Notice of Request for Extension and Revision of a Currently Approved...

  13. 75 FR 36059 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-24

    ... specialty crops, in specified production areas, to work together to solve marketing problems that cannot be... Agricultural Marketing Service Notice of Request for Extension and Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY:...

  14. 75 FR 36058 - Notice of Request for Extension and Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-24

    ... production areas, to work together to solve marketing problems that cannot be solved individually. This...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service Notice of Request for Extension and Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice...

  15. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Science.gov (United States)

    2010-01-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE Foreign-Trade Zones Board Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago, IL, Area Pursuant to its authority under the...

  16. 7 CFR 58.122 - Approved plants under USDA inspection and grading service.

    Science.gov (United States)

    2010-01-01

    ...) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) REGULATIONS AND STANDARDS UNDER THE AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS... and Grading Service 1 Purpose § 58.122 Approved plants under USDA inspection and grading service....

  17. 75 FR 15673 - Notice of Request for Extension of Approval of an Information Collection; Export Health...

    Science.gov (United States)

    2010-03-30

    ... certification must carry the USDA seal and be endorsed by an APHIS representative (e.g., a Veterinary Medical... Veterinary Services (VS) Forms 16-4 (Export Health Certificate for Animal Products) and 16- 4A (Continuation... for OMB approval. All comments will also become a matter of public record. Done in Washington,...

  18. 76 FR 24060 - Proposed Extension of Existing Information Collection; Testing, Evaluation, and Approval of...

    Science.gov (United States)

    2011-04-29

    ... Safety and Health Administration Proposed Extension of Existing Information Collection; Testing, Evaluation, and Approval of Mining Products AGENCY: Mine Safety and Health Administration. ACTION: Notice of... information in accordance with the Paperwork Reduction Act of 1995 . This program helps to ensure...

  19. 7 CFR 205.622 - Review of approved State organic programs.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Review of approved State organic programs. 205.622... MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Administrative State Organic...

  20. 77 FR 6057 - Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation...

    Science.gov (United States)

    2012-02-07

    ... Foreign-Trade Zones Board Approval for Manufacturing Authority, Foreign-Trade Zone 22, Baxter Healthcare Corporation, (Pharmaceutical and Biological Intravenous Product Manufacturing), Chicago, IL Pursuant to its... District, grantee of Foreign-Trade Zone 22, has requested manufacturing authority on behalf of...

  1. [State of Michigan Teacher Education Manual 1970, Sections I and II--Approval of Teacher Education Institutions and Approval of Teacher Education Programs at Approved Teacher Education Institutions].

    Science.gov (United States)

    Michigan State Dept. of Education, Lansing. Teacher Preparation and Professional Development Services.

    This document presents rules and regulations of the Michigan State Board of Education concerning procedures for the approval of teacher education institutions and teacher education programs. The first section details processes in institutional approval, presenting: (1) legislative authority; (2) characteristics of the Approved Program System; (3)…

  2. High Falls generation station expansion approvals process

    Energy Technology Data Exchange (ETDEWEB)

    Litschko, C. [Lakeland Holding, Bracebridge, ON (Canada)

    2005-07-01

    Lakeland Holding Ltd. is the parent company for Lakeland Power Distribution Ltd., Bracebridge Generation Ltd., and Lakeland Energy Ltd. This PowerPoint presentation highlighted the High Falls generation expansion process. During construction of the High Falls plant, a concrete foundation was built beside the plant for future expansion. The expansion process involves building a 1,500 kilowatt generator to supply electricity to as many as 1600 households. The presentation described the context and background for the expansion and presented information on the water power generation plants. It presented site specifications as well as the approvals process by which final approval was granted in 2004. Observations and lessons learned from the approval process were identified. figs.

  3. From Measurements to Site Approval

    DEFF Research Database (Denmark)

    Toft, Henrik Stensgaard; Svenningsen, Lasse; Sørensen, John Dalsgaard

    2014-01-01

    for the turbulence and average values for the wind shear and air density. The analysis in the present paper shows that wind shear variations can have a significant influence on fatigue loads for some wind turbine sensors (components). The natural variation in shear should therefore be taken into account in site......In the present paper the influence of natural variations in turbulence, wind shear and air density on the fatigue damage equivalent loads during power production are investigated. In site suitability analysis it is normally assumed that the fatigue loads can be estimated based on a 90% quantile...

  4. 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.

  5. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  6. 40 CFR 52.2522 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... provisions do not meet the requirements of 40 CFR 51.160 for scope. EPA also disapproves 45 CSR 13 section 9... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Approval status. 52.2522 Section 52.2522 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS...

  7. Approved Practices in Dairy Reproduction. Slide Script.

    Science.gov (United States)

    Roediger, Roger D.; Barr, Harry L.

    This slide script, part of a series of slide scripts designed for use in vocational agriculture classes, deals with approved practices in dairy reproduction. Included in the guide are narrations for use with 200 slides dealing with the following topics: the importance of good reproduction, the male and female roles in reproduction, selection of…

  8. 42 CFR 422.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 422.2266 Section 422.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Medicare Advantage Marketing Requirements § 422.2266...

  9. 42 CFR 423.2266 - Deemed approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Deemed approval. 423.2266 Section 423.2266 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Part D Marketing Requirements §...

  10. 7 CFR 322.4 - Approved regions.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Approved regions. 322.4 Section 322.4 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS, AND BEEKEEPING EQUIPMENT Importation of...

  11. 7 CFR 1425.4 - Approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS, PURCHASES, AND OTHER OPERATIONS COOPERATIVE MARKETING ASSOCIATIONS § 1425.4 Approval. (a) For a cooperative to gain CMA status to participate in a marketing assistance loan or Loan deficiency... prepared in accordance with generally accepted accounting principles; (3) A copy of the articles...

  12. Perkins Bill is Approved by Congress

    Science.gov (United States)

    Cavanagh, Sean

    2006-01-01

    Career and technical education programs will face new pressure to show that they are academically rigorous and guiding high school students through a lineup of courses that prepares them for college or the workplace, under a bill approved by Congress. The reauthorization of the federal law known as the Perkins Act--dealing with what traditionally…

  13. Program and Course Approval Handbook. Fifth Edition

    Science.gov (United States)

    California Community Colleges, Chancellor's Office, 2013

    2013-01-01

    This "Program and Course Approval Handbook" assists California Community College (CCC) administrators, faculty, and staff in the development of programs and courses and the submission of these proposals for review by the Chancellor's Office. By law, the Chancellor is required to prepare and distribute a handbook for program and course…

  14. 7 CFR 3565.103 - Approval requirements.

    Science.gov (United States)

    2010-01-01

    ... lender must provide the Agency with an annual audited financial statement conducted in accordance with... reserves, to have an acceptable level of financial soundness as determined by a lender rating service (such... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Lender Requirements § 3565.103 Approval requirements....

  15. Approval of Spouse in Middle Age.

    Science.gov (United States)

    Troll, Lillian E.

    A strongly positive opinion of spouse in middle age tends to be associated with social conformity and family integration. Mutually approving couples were more often politically moderate, homogamous in religious background, and had more interpersonal power than their children. They also had more highly integrated family structures with low conflict…

  16. 28 CFR 48.15 - Temporary approval.

    Science.gov (United States)

    2010-07-01

    ... Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) NEWSPAPER PRESERVATION ACT § 48.15 Temporary... temporary approval may do so by delivering a statement of protest or telephoning his views to an employee of the Department of Justice, whose name, address and telephone number shall be designated by...

  17. 7 CFR 3015.112 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Approval procedures. 3015.112 Section 3015.112 Agriculture Regulations of the Department of Agriculture (Continued) OFFICE OF THE CHIEF FINANCIAL OFFICER, DEPARTMENT OF AGRICULTURE UNIFORM FEDERAL ASSISTANCE REGULATIONS Programmatic Changes and Budget...

  18. Reflections on the Ethics-Approval Process

    Science.gov (United States)

    Murray, Lee; Pushor, Debbie; Renihan, Pat

    2012-01-01

    It is sometimes a difficult journey receiving ethics approval for research involving vulnerable populations, research involving our own children, or innovative research methodologies such as autoethnography. This autoethnographical account is a story about one student who wanted to write a PhD dissertation in a very different way and also the…

  19. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICES Plastic Surgery § 549.51 Approval procedures. The Clinical Director shall consider individually any request from an inmate or a BOP medical consultant. (a) In circumstances where plastic surgery is... the Clinical Director recommends plastic surgery for the good order and security of the...

  20. 40 CFR 1042.210 - Preliminary approval.

    Science.gov (United States)

    2010-07-01

    ... specific provisions that apply for deterioration factors. Decisions made under this section are considered... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Preliminary approval. 1042.210 Section 1042.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION...

  1. 40 CFR 52.373 - Approval status.

    Science.gov (United States)

    2010-07-01

    ... approves the total suspended particulate regulation for foundry sand processes as submitted and identified... the particulate matter and not the requirement to emit not more than 0.75 pounds of particulate per ton of material cast, a provision which may be found in state regulation 19-508-18(f)(3)....

  2. 7 CFR 52.53 - Approved identification.

    Science.gov (United States)

    2010-01-01

    ...) When graded against a U.S. grade standard, meet the quality requirements for U.S Grade C or better; (5) Meet applicable fill weight and/or drained weight, Brix or other characteristics of a commodity related... approved by USDA inspection service prior to use. (b) Inspection (Continuous) grade and inspection...

  3. Gene therapy for cancer: regulatory considerations for approval.

    Science.gov (United States)

    Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

    2015-12-01

    The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

  4. 9 CFR 54.11 - Approval of laboratories to run official scrapie tests and official genotype tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approval of laboratories to run official scrapie tests and official genotype tests. 54.11 Section 54.11 Animals and Animal Products ANIMAL... laboratories to run official scrapie tests and official genotype tests. (a) State, Federal, and...

  5. 9 CFR 78.11 - Cattle moved to a specifically approved stockyard not in accordance with this part.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Cattle moved to a specifically... (INCLUDING POULTRY) AND ANIMAL PRODUCTS BRUCELLOSIS Restrictions on Interstate Movement of Cattle Because of Brucellosis § 78.11 Cattle moved to a specifically approved stockyard not in accordance with this part....

  6. 77 FR 13070 - Notice of Request for Approval of a New Information Collection for Export/Health Certificate Forms

    Science.gov (United States)

    2012-03-05

    ... States. Exporters must request export certificates from USDA, AMS, Dairy Grading Branch if the importing... approval, from the Office of Management and Budget, for export certificate request forms for dairy products. There are currently 17 different export certificate request forms for dairy products with more...

  7. 46 CFR 162.050-23 - Separator: Approval tests.

    Science.gov (United States)

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Pollution Prevention Equipment § 162.050-23 Separator: Approval... hour, the separator must be inclined at an angle of 22.5° with the plane of its normal...

  8. FDA Approves New Treatment for Dust Mite Allergies

    Science.gov (United States)

    ... page: https://medlineplus.gov/news/fullstory_163882.html FDA Approves New Treatment for Dust Mite Allergies Odactra ... life," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The approval ...

  9. 28 CFR 551.11 - Authority to approve a marriage.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Authority to approve a marriage. 551.11... MISCELLANEOUS Marriages of Inmates § 551.11 Authority to approve a marriage. (a) The Warden may approve the marriage of a federal inmate confined in a federal institution. This authority may not be delegated...

  10. 50 CFR 15.26 - Approval of cooperative breeding programs.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 1 2010-10-01 2010-10-01 false Approval of cooperative breeding programs... WILDLIFE AND PLANTS WILD BIRD CONSERVATION ACT Permits and Approval of Cooperative Breeding Programs § 15.26 Approval of cooperative breeding programs. Upon receipt of a complete application, the...

  11. 29 CFR 4221.14 - PBGC-approved arbitration procedures.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false PBGC-approved arbitration procedures. 4221.14 Section 4221... LIABILITY FOR MULTIEMPLOYER PLANS ARBITRATION OF DISPUTES IN MULTIEMPLOYER PLANS § 4221.14 PBGC-approved arbitration procedures. (a) Use of PBGC-approved arbitration procedures. In lieu of the procedures...

  12. 12 CFR 614.4470 - Loans subject to bank approval.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loans subject to bank approval. 614.4470 Section 614.4470 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS Loan Approval Requirements § 614.4470 Loans subject to bank approval. (a) The following...

  13. 33 CFR 115.70 - Advance approval of bridges.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Advance approval of bridges. 115... BRIDGES BRIDGE LOCATIONS AND CLEARANCES; ADMINISTRATIVE PROCEDURES § 115.70 Advance approval of bridges. (a) The General Bridge Act of 1946 requires the approval of the location and plans of bridges...

  14. 14 CFR 21.269 - Export airworthiness approvals.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Export airworthiness approvals. 21.269 Section 21.269 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION....269 Export airworthiness approvals. The manufacturer may issue export airworthiness approvals....

  15. 76 FR 53526 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-08-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  16. 76 FR 42159 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-07-18

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., receiving approval for the consumptive use of water pursuant to the Commission's approval by rule...

  17. 48 CFR 32.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Recommendation for... Recommendation for approval. If recommending approval, the contracting officer shall transmit the following... authorization (see 32.410). (g) The recommendation for approval of the advance payment request....

  18. 8 CFR 207.6 - Control over approved refugee numbers.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Control over approved refugee numbers. 207... ADMISSION OF REFUGEES § 207.6 Control over approved refugee numbers. Current numerical accounting of approved refugees is maintained for each special group designated by the President. As refugee status...

  19. 29 CFR 4211.21 - Changes subject to PBGC approval.

    Science.gov (United States)

    2010-07-01

    ... method or modification to an allocation method that is not permitted under § 4211.12 if the method or... 29 Labor 9 2010-07-01 2010-07-01 false Changes subject to PBGC approval. 4211.21 Section 4211.21... Subject to PBGC Approval § 4211.21 Changes subject to PBGC approval. (a) General rule. Subject to...

  20. 44 CFR 78.9 - Planning grant approval process.

    Science.gov (United States)

    2010-10-01

    ... MITIGATION ASSISTANCE § 78.9 Planning grant approval process. The State POC will evaluate and approve... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Planning grant approval process. 78.9 Section 78.9 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT...

  1. 48 CFR 1845.607-170 - Contractor's approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Contractor's approved scrap... Contractor Inventory 1845.607-170 Contractor's approved scrap procedure. (a) When a contractor has an approved scrap procedure, certain property may be routinely disposed of in accordance with that...

  2. 46 CFR 188.10-3 - Approved container.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Approved container. 188.10-3 Section 188.10-3 Shipping... PROVISIONS Definition of Terms Used in This Subchapter § 188.10-3 Approved container. This term means a container which is properly labeled, marked and approved by DOT for the commodity which it contains....

  3. 7 CFR 996.22 - USDA-approved laboratory.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 8 2010-01-01 2010-01-01 false USDA-approved laboratory. 996.22 Section 996.22 Agriculture Regulations of the Department of Agriculture (Continued) AGRICULTURAL MARKETING SERVICE (Marketing... laboratory. USDA-approved laboratory means laboratories approved by the Science and Technology...

  4. Sincere Voting with Cardinal Preferences: Approval Voting

    OpenAIRE

    Ballester, Miguel Angel; Rey-Biel, Pedro

    2007-01-01

    We discuss sincere voting when voters have cardinal preferences over alter- natives. We interpret sincerity as opposed to strategic voting, and thus define sincerity as the optimal behaviour when conditions to vote strategically vanish. When voting mechanisms allow for only one message type we show that this op- timal behaviour coincides with an intuitive and common definition of sincerity. For voting mechanisms allowing for multiple message types, such as approval vot- ing (AV), there exists...

  5. Thiazolidinediones: a comparative review of approved uses.

    Science.gov (United States)

    Sood, V; Colleran, K; Burge, M R

    2000-01-01

    Thiazolidinediones are a powerful and clinically important new class of oral antidiabetic agents that act by improving insulin sensitivity. Troglitazone is the prototype drug in this class but was withdrawn from the market in March 2000 due to its association with idiosyncratic hepatotoxicity. Currently two thiazolidinediones, rosiglitazone and pioglitazone, are U.S. Food and Drug Administration (FDA) approved for treatment of type 2 diabetes. These agents bind to and activate peroxisome proliferator-activator receptor gamma (PPAR-gamma) and work by altering the expression of genes involved in glucose uptake, glucose disposal, and lipid metabolism. The drugs differ in receptor binding and potency due to differences in their side chain moieties. These agents are rapidly absorbed from the gastrointestinal tract and are metabolized mainly in the liver. Rosiglitazone is FDA approved for monotherapy and for use in combination therapy with metformin or sulfonylureas. Pioglitazone is FDA approved for monotherapy as well as for use in combination therapy with metformin, insulin, or sulfonylureas. These drugs may also cause significant changes in plasma lipid concentrations, and improved insulin sensitivity may improve ovulatory function and fertility in women with polycystic ovary syndrome. The most serious side effect of the thiazolidinediones is hepatotoxicity. Although rosiglitazone and pioglitazone were not associated with hepatotoxicity in premarketing clinical trials, there were two recent case reports of idiosyncratic hepatotoxicity in patients treated with rosiglitazone. In addition, these agents may be associated with edema and some hematological changes. The purpose of this review is to provide an overview of the two currently approved thiazolidinediones and to suggest an approach for their safe and rational use.

  6. Radiation Emitting Product Corrective Actions and Recalls

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database provides descriptions of radiation-emitting products that have been recalled under an approved corrective action plan to remove defective and...

  7. [Approval of a bone bank: an institution's experience].

    Science.gov (United States)

    Jung, S; Wernerus, D; Reichel, H

    2012-03-01

    The new tissue laws of 2007 created a completely new situation for German musculoskeletal tissue banks. The objective of the new regulations in the recent German tissue act is to improve safety by reducing the risk of transmission of viral and nonviral diseases. Since 2007 tissue banks have to declare their intention to continue providing allografts to the local authorities until August 2011 based on the guidelines of the Federal Medical Association (Bundesärztekammer 2001) and according to § 144 of the Pharmaceutical Products Act (Arzneimittelgesetz). The Orthopedic University Clinic in Ulm applied for registration according to § 20 b and c of the Pharmaceutical Products Act in 2010. After submitting all the required documents, government officials controlled the equipment, distribution of responsible personnel, location of operating theatres and the laboratory and quality assurance documentation. After alluding to the lack of validation for the use of a hemoculture medium for testing ringer lactate solutions, permission according to § 20 b and c was granted with the obligation to transfer all serological and microbiological testing of tissue donors to another laboratory with its own approval under § 20 c of the Pharmaceutical Products Act.

  8. Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition.

    Science.gov (United States)

    Evens, Ronald P

    2016-01-01

    The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recombinant human insulin in 1982, originating from the Genentech company. The pharma industry in the early years of 1970s and 1980s engaged with biotechnology companies only to a small extent with their in-licensing of a few recombinant molecules, led by Roche, Eli Lilly, and Johnson and Johnson. However, subsequently and dramatically over the last 25 years, biotechnology has become a primary driver of product and technology innovation and has become a cornerstone in new product development by all biopharma companies. This review demonstrates these evolutionary changes regarding approved products, product pipelines, novelty of the products, FDA approval rates, product sales, financial R&D investments in biotechnology, partnerships, mergers and acquisitions, and patent issues. We now have about 300 biotechnology products approved in USA covering 16 medical disciplines and about 250 indications, with the engagement of 25 pharma companies, along with their biotechnology company innovators and partners. The biotechnology pipeline involves over 1000 molecules in clinical trials, including over 300 molecules associated with the top 10 pharma companies. Product approval rates by the FDA for biotechnology products are over double the rate for drugs. Yes, the R&D paradigm has changed with biotechnology now as one of the major focuses for new product development with novel molecules by the whole biopharma industry.

  9. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2012-08-06

    ... Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... substantially contribute to, market approval of these products. Applicants must include in the application's... either help support product approval or provide essential data needed for product development....

  10. Shanghai-Nanjing Intercity Railway Approved

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    @@ The feasibility study on Shanghai-Nanjing and Shanghai-Hangzhou Intercity Railways were approved officially by the National Reform and Development Commission (NRDC). The Shanghai-Nanjing Intercity Railway will be located briefly in parallel with the existing Shanghai-Nanjing Railway, starting from Shanghai and ending at Nanjing via Kunshan, Suzhou,Wuxi, Changzhou, Danyang and Zhenjiang, with a total length of 300 km for the main line, among which 32km will be in Shanghai and 268 km in Jiangsu Province.

  11. Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

    Science.gov (United States)

    Leyens, Lada; Richer, Étienne; Melien, Øyvind; Ballensiefen, Wolfgang; Brand, Angela

    2015-01-01

    Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues.

  12. 21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use...; (7) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in part 56 of this chapter or the informed consent regulations in part...

  13. 7 CFR 58.519 - Dairy products.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Dairy products. 58.519 Section 58.519 Agriculture..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General... Material § 58.519 Dairy products. (a) Raw skim milk. All raw skim milk obtained from a secondary...

  14. Beware of Products Promising Miracle Weight Loss

    Science.gov (United States)

    ... firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure ... seized products, and criminally prosecuted people responsible for marketing these illegal diet products. In addition, FDA maintains an online list of ...

  15. 21 CFR 820.90 - Nonconforming product.

    Science.gov (United States)

    2010-04-01

    ... procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in...

  16. 78 FR 29784 - New Postal Product

    Science.gov (United States)

    2013-05-21

    ... New Postal Product AGENCY: Postal Regulatory Commission. ACTION: Notice SUMMARY: The Commission is... Contract to the competitive product list. This notice informs the public of the filing, invites public... included within the GEPS 3 product on grounds of functional equivalence to a previously approved...

  17. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    Science.gov (United States)

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  18. 14 CFR 171.25 - Minimum requirements for approval.

    Science.gov (United States)

    2010-01-01

    ... (CONTINUED) NAVIGATIONAL FACILITIES NON-FEDERAL NAVIGATION FACILITIES Nondirectional Radio Beacon Facilities... met before the FAA will approve an IFR procedure for a non-Federal, nondirectional radio...

  19. Evaluation of genotoxicity testing of FDA approved large molecule therapeutics.

    Science.gov (United States)

    Sawant, Satin G; Fielden, Mark R; Black, Kurt A

    2014-10-01

    Large molecule therapeutics (MW>1000daltons) are not expected to enter the cell and thus have reduced potential to interact directly with DNA or related physiological processes. Genotoxicity studies are therefore not relevant and typically not required for large molecule therapeutic candidates. Regulatory guidance supports this approach; however there are examples of marketed large molecule therapeutics where sponsors have conducted genotoxicity studies. A retrospective analysis was performed on genotoxicity studies of United States FDA approved large molecule therapeutics since 1998 identified through the Drugs@FDA website. This information was used to provide a data-driven rationale for genotoxicity evaluations of large molecule therapeutics. Fifty-three of the 99 therapeutics identified were tested for genotoxic potential. None of the therapeutics tested showed a positive outcome in any study except the peptide glucagon (GlucaGen®) showing equivocal in vitro results, as stated in the product labeling. Scientific rationale and data from this review indicate that testing of a majority of large molecule modalities do not add value to risk assessment and support current regulatory guidance. Similarly, the data do not support testing of peptides containing only natural amino acids. Peptides containing non-natural amino acids and small molecules in conjugated products may need to be tested.

  20. 9 CFR 316.7 - Marking devices not to be false or misleading; style and size of lettering; approval required.

    Science.gov (United States)

    2010-01-01

    ... figures thereon shall be of such style and type as will make a clear and legible impression. All markings... misleading; style and size of lettering; approval required. 316.7 Section 316.7 Animals and Animal Products... AND THEIR CONTAINERS § 316.7 Marking devices not to be false or misleading; style and size...

  1. 75 FR 52709 - Notice of Request for Extension of Approval of an Information Collection; Importation of Animals...

    Science.gov (United States)

    2010-08-27

    ...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an Information Collection; Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, Semen, and Zoological Animals AGENCY: Animal and Plant Health Inspection...

  2. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  3. 7 CFR 205.621 - Submission and determination of proposed State organic programs and amendments to approved State...

    Science.gov (United States)

    2010-01-01

    ..., Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL... 7 Agriculture 3 2010-01-01 2010-01-01 false Submission and determination of proposed State organic programs and amendments to approved State organic programs. 205.621 Section 205.621 Agriculture...

  4. 21 CFR 515.25 - Revocation of order refusing to approve a medicated feed mill license application or suspending...

    Science.gov (United States)

    2010-04-01

    ... medicated feed mill license application or suspending or revoking a license. 515.25 Section 515.25 Food and..., FEEDS, AND RELATED PRODUCTS MEDICATED FEED MILL LICENSE Administrative Actions on Licenses § 515.25 Revocation of order refusing to approve a medicated feed mill license application or suspending or revoking...

  5. Bromocriptine mesylate: Food and Drug Administration approved new approach in therapy of non-insulin dependant diabetes mellitus with poor glycemic control

    OpenAIRE

    Yogendra Keche

    2010-01-01

    Food and Drug Administration (FDA) approved bromocriptine mesylate, a quick release formulation, 0.8 mg tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Bromocriptine products were previously approved by the FDA for the treatment of pituitary tumors and Parkinson's disease. Bromocriptine is thought to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma ...

  6. 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

  7. 10 CFR 25.8 - Information collection requirements: OMB approval.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 25.8 Section 25.8 Energy NUCLEAR REGULATORY COMMISSION ACCESS AUTHORIZATION General Provisions § 25.8...), 25.21(c), 25.27(b), 25.29, and 25.31, SF-86 is approved under control number 3206-0007. (3) In §...

  8. Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers

    Science.gov (United States)

    ... Quiz Cancers by Body Location/System Childhood Cancers Late Effects of Childhood Cancer Treatment Pediatric Supportive Care Unusual Cancers of ... Research Drugs Approved for Wilms Tumor and Other Childhood Kidney Cancers ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and ...

  9. 32 CFR 644.135 - Lease authorization and approvals.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Lease authorization and approvals. 644.135... PROPERTY REAL ESTATE HANDBOOK Acquisition Acquisition by Leasing § 644.135 Lease authorization and approvals. (a) Title 10 Reports. Under the provisions of 10 U.S.C. 2662, a lease proposal or renewal with...

  10. 49 CFR 107.403 - Designation of approval agencies.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Designation of approval agencies. 107.403 Section 107.403 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS... MATERIALS PROGRAM PROCEDURES Designation of Approval and Certification Agencies § 107.403 Designation...

  11. 50 CFR Appendix B to Part 404 - Approved VMS

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Approved VMS B Appendix B to Part 404... MARINE NATIONAL MONUMENT Pt. 404, App. B Appendix B to Part 404—Approved VMS I. VMS Mobile Transceiver Unit Thrane & Thrane Sailor 3026D Gold VMS The Thrane & Thrane Sailor 3026D Gold VMS (TT-3026D)...

  12. 12 CFR 614.4460 - Loan approval responsibility.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Loan approval responsibility. 614.4460 Section 614.4460 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM LOAN POLICIES AND OPERATIONS... approval of such loans by the appropriate bank board, or establishment of a policy under which...

  13. Electronic Approval: Another Step toward a Paperless Office.

    Science.gov (United States)

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

    Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

  14. 13 CFR 302.18 - Post-approval requirements.

    Science.gov (United States)

    2010-01-01

    ... GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.18 Post-approval requirements. (a) General. A... the terms and conditions of the Investment Assistance, including any special terms and applicable Federal cost principles (collectively, “Post-Approval Requirements”). A Recipient's failure to comply...

  15. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

    ... communicable diseases. (b) The Commissioner of Food and Drugs may base his approval or disapproval of a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of watering points. 1240.83 Section 1240.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  16. Hyapproval : final handbook for approval of hydrogen refuelling stations

    NARCIS (Netherlands)

    Wurster, R.; Landinger, H.; Machens, C.; Allidières, L.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.

    2006-01-01

    HyApproval is an EC co-financed Specific Targeted Research Project (STREP) to develop a Handbook facilitating the approval of Hydrogen Refuelling Stations (HRS). The project, started in October 2005, will be performed over 24 months by a balanced partnership including 25 partners from industry, SMEs

  17. 78 FR 37848 - ASME Code Cases Not Approved for Use

    Science.gov (United States)

    2013-06-24

    ... COMMISSION ASME Code Cases Not Approved for Use AGENCY: Nuclear Regulatory Commission. ACTION: Draft... public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC...

  18. 77 FR 55891 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  19. 77 FR 16317 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-03-20

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  20. 77 FR 66909 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-11-07

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  1. 76 FR 66117 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2011-10-25

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  2. 77 FR 4859 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-01-31

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION..., described below, receiving approval for the consumptive use of water pursuant to the Commission's...

  3. 77 FR 34455 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-06-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  4. 77 FR 55892 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-11

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  5. 77 FR 59239 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-09-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  6. 77 FR 25010 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-26

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the...

  7. 77 FR 21143 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2012-04-09

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin Commission. ACTION... consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR...

  8. 14 CFR 135.419 - Approved aircraft inspection program.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approved aircraft inspection program. 135.419 Section 135.419 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF... Maintenance, Preventive Maintenance, and Alterations § 135.419 Approved aircraft inspection program....

  9. 48 CFR 232.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Recommendation for approval. 232.409-1 Section 232.409-1 Federal Acquisition Regulations System DEFENSE ACQUISITION... for Non-Commercial Items 232.409-1 Recommendation for approval. Follow the procedures at PGI...

  10. 48 CFR 332.409-1 - Recommendation for approval.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Recommendation for approval. 332.409-1 Section 332.409-1 Federal Acquisition Regulations System HEALTH AND HUMAN SERVICES... Recommendation for approval. The Contracting Officer shall transmit the information in FAR 32.409-1 (or FAR...

  11. Additional safety risk to exceptionally approved drugs in Europe?

    NARCIS (Netherlands)

    Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; Eichler, Hans-Georg; de Graeff, Pieter A.; Mol, Peter G. M.

    2011-01-01

    AIMS Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of

  12. 40 CFR 1065.12 - Approval of alternate procedures.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Approval of alternate procedures. 1065.12 Section 1065.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS ENGINE-TESTING PROCEDURES Applicability and General Provisions § 1065.12 Approval...

  13. For the approval process of GMOs: The Japanese case

    NARCIS (Netherlands)

    Ebata, A.; Punt, M.J.; Wesseler, J.H.H.

    2013-01-01

    This article reviews the approval process of genetically modified organisms (GMOs) in Japan. The purpose of this review is to explain the Japanese safety approval procedures for food, feed, and imported GMOs and place it in an international context through a comparison with the United States and the

  14. 42 CFR 433.117 - Initial approval of replacement systems.

    Science.gov (United States)

    2010-10-01

    ... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system...

  15. 28 CFR 512.17 - Monitoring approved research projects.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Monitoring approved research projects. 512.17 Section 512.17 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE GENERAL MANAGEMENT AND ADMINISTRATION RESEARCH Research § 512.17 Monitoring approved research projects. The...

  16. 78 FR 28620 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-05-15

    ... Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval..., competitive, and organized group recreational uses of the public lands, and individual use of special...

  17. 76 FR 20070 - Commercial Space Transportation Safety Approval Performance Criteria

    Science.gov (United States)

    2011-04-11

    ... Federal Aviation Administration Commercial Space Transportation Safety Approval Performance Criteria... received, a safety approval for the ability of its Space Training System: Model 400 (STS-400) to replicate....19 (a)(4). NASTAR's ] STS-400 suborbital space flight simulator (a multi-axis centrifuge) is...

  18. Waste Feed Delivery Environmental Permits and Approvals Plan

    Energy Technology Data Exchange (ETDEWEB)

    TOLLEFSON, K.S.

    2000-01-18

    This plan describes the environmental permits approvals, and other requirements that may affect establishment of a waste feed delivery system for the Hanford Site's River Protection Project. This plan identifies and screens environmental standards for potential applicability, outlines alternatives for satisfying applicable standards, and describes preferred permitting and approval approaches.

  19. 12 CFR 918.5 - Approval by Finance Board.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Approval by Finance Board. 918.5 Section 918.5 Banks and Banking FEDERAL HOUSING FINANCE BOARD GOVERNANCE AND MANAGEMENT OF THE FEDERAL HOME LOAN BANKS BANK DIRECTOR COMPENSATION AND EXPENSES § 918.5 Approval by Finance Board. Payments made to...

  20. 24 CFR 886.107 - Approval of applications.

    Science.gov (United States)

    2010-04-01

    ...) The Owner's Affirmative Fair Housing Marketing Plan is approvable. (b) The HUD-approved unit rents are.... Occupancy requirements are being met. Marketing and maintenance programs are being carried out in an... collection losses. (7) The Owner's plan for remedying any deferred maintenance, financial problems, or...

  1. 30 CFR 75.600-1 - Approved cables; flame resistance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant....

  2. How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

    Science.gov (United States)

    Bogaert, Peter; Van Keymeulen, Eveline

    2012-09-01

    This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts.

  3. HyApproval - Handbook for the approval of hydrogen refuelling stations - First preliminary achievements

    Energy Technology Data Exchange (ETDEWEB)

    Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.

    2007-05-15

    The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)

  4. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2010-08-06

    ... Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... substantially contribute to, market approval of these products. Applicants must include in the application's... proposed study will either help support product approval or provide essential data needed for...

  5. 77 FR 13294 - Announcing Approval of Federal Information Processing Standard (FIPS) Publication 180-4, Secure...

    Science.gov (United States)

    2012-03-06

    ... National Institute of Standards and Technology Announcing Approval of Federal Information Processing... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) Publication... announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS)...

  6. Characterization of spent fuel approved testing material--ATM-104

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Jenquin, U.P.; Mendel, J.E.; Thomas, L.E.; Thornhill, C.K.

    1991-12-01

    The characterization data obtained to date are described for Approved Testing Material 104 (ATM-104), which is spent fuel from Assembly DO47 of the Calvert Cliffs Nuclear Power Plant (Unit 1), a pressurized-water reactor. This report is one in a series being prepared by the Materials Characterization Center at Pacific Northwest Laboratory (PNL) on spent fuel ATMs. The ATMs are receiving extensive examinations to provide a source of well-characterized spent fuel for testing in the US Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Program. ATM-104 consists of 128 full-length irradiated fuel rods with rod-average burnups of about 42 MWd/kgM and expected fission gas release of about 1%. A variety of analyses were performed to investigate cladding characteristics, radionuclide inventory, and redistribution of fission products. Characterization data include (1) fabricated fuel design, irradiation history, and subsequent storage and handling history; (2) isotopic gamma scans; (3) fission gas analyses; (4) ceramography of the fuel and metallography of the cladding; (5) special fuel studies involving analytical transmission electron microscopy (AEM) and electron probe microanalyses (EPMA); (6) calculated nuclide inventories and radioactivities in the fuel and cladding; and (7) radiochemical analyses of the fuel and cladding.

  7. Modelling seasonality in Australian building approvals

    Directory of Open Access Journals (Sweden)

    Harry M Karamujic

    2012-02-01

    Full Text Available The paper examines the impact of seasonal influences on Australian housing approvals, represented by the State of Victoria[1] building approvals for new houses (BANHs. The prime objective of BANHs is to provide timely estimates of future residential building work. Due to the relevance of the residential property sector to the property sector as whole, BANHs are viewed by economic analysts and commentators as a leading indicator of property sector investment and as such the general level of economic activity and employment. The generic objective of the study is to enhance the practice of modelling housing variables. In particular, the study seeks to cast some additional light on modelling the seasonal behaviour of BANHs by: (i establishing the presence, or otherwise, of seasonality in Victorian BANHs; (ii if present, ascertaining is it deterministic or stochastic; (iii determining out of sample forecasting capabilities of the considered modelling specifications; and (iv speculating on possible interpretation of the results. To do so the study utilises a structural time series model of Harwey (1989. The modelling results confirm that the modelling specification allowing for stochastic trend and deterministic seasonality performs best in terms of diagnostic tests and goodness of fit measures. This is corroborated with the analysis of out of sample forecasting capabilities of the considered modelling specifications, which showed that the models with deterministic seasonal specification exhibit superior forecasting capabilities. The paper also demonstrates that if time series are characterized by either stochastic trend or seasonality, the conventional modelling approach[2] is bound to be mis-specified i.e. would not be able to identify statistically significant seasonality in time series.According to the selected modeling specification, factors corresponding to June, April, December and November are found to be significant at five per cent level

  8. Japanese regulation of biosimilar products: past experience and current challenges.

    Science.gov (United States)

    Arato, Teruyo

    2016-07-01

    Seven biosimilar products have been approved in Japan since the March 2009 publication of the 'Guideline for quality, safety and efficacy assurance of biosimilar products' by the Ministry of Health, Labor and Welfare (MHLW). Four years previously, the 'Guideline on similar biological medicinal products' was issued in the European Union (EU), and 13 products as of February 2016 have been approved as biosimilar. The US Food and Drug Administration (FDA) approved the first biosimilar product in the US in March 2015 and final Guidance was issued at the end of April 2015. Over the past decade, the challenges regarding the development of biosimilar products have been discussed extensively. In this article, the data packages of biosimilar products in Japan are compared with those overseas in order to clarify the concepts used by the Japanese regulatory authority, i.e., the Pharmaceuticals and Medical Devices Agency (PMDA). The challenges in the development of biosimilar products in Japan are also addressed.

  9. 7 CFR 58.627 - Milk and dairy products.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Milk and dairy products. 58.627 Section 58.627..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 General... Material § 58.627 Milk and dairy products. To produce ice cream and related products the raw milk and...

  10. 7 CFR 58.235 - Modified dry milk products.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Modified dry milk products. 58.235 Section 58.235... Materials § 58.235 Modified dry milk products. Dry milk products to which approved neutralizing agents or... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) GRADING AND...

  11. 75 FR 39619 - Proposed Information Collection (Quarterly Report of State Approving Agency) Activities Activity...

    Science.gov (United States)

    2010-07-09

    ... expenses incurred in the approval and supervision of education and training programs. DATES: Written... collection. Abstract: VA reimburses SAAs for expenses incurred in the approval and supervision of...

  12. 75 FR 13337 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-03-19

    .... Security improvements. Snow equipment purchase--liquid deice truck. Brief Description of Project Approved... annual enplanements at Dallas Love Field. Brief Description of Projects Approved for Collection and...

  13. Phage approved in food, why not as a therapeutic?

    Science.gov (United States)

    Sarhan, Wessam A; Azzazy, Hassan M E

    2015-01-01

    Bacterial resistance is not only restricted to human infections but is also a major problem in food. With the marked decrease in produced antimicrobials, the world is now reassessing bacteriophages. In 2006, ListShield™ received the US FDA approval for using phage in food. Nevertheless, regulatory approval of phage-based therapeutics is still facing many challenges. This review highlights the use of bacteriophages as biocontrol agents in the food industry. It also focuses on the challenges still facing the regulatory approval of phage-based therapeutics and the proposed approaches to overcome such challenges.

  14. How to Select Anti-Aging Skin Care Products

    Science.gov (United States)

    ... for public Dermatology World Dialogues in Dermatology JAAD Mohs AUC MyDermPath+ Psoriasis Patient education resources Practice Management ... clinical trials and received approval from the U.S. Food and Drug Administration (FDA). Select a product within ...

  15. Chemical Diversity of Metabolites from Fungi, Cyanobacteria, and Plants Relative to FDA-Approved Anticancer Agents.

    Science.gov (United States)

    El-Elimat, Tamam; Zhang, Xiaoli; Jarjoura, David; Moy, Franklin J; Orjala, Jimmy; Kinghorn, A Douglas; Pearce, Cedric J; Oberlies, Nicholas H

    2012-07-12

    A collaborative project has been undertaken to explore filamentous fungi, cyanobacteria, and tropical plants for anti-cancer drug leads. Through principal component analysis, the chemical space covered by compounds isolated and characterized from these three sources over the last four years was compared to each other and to the chemical space of selected FDA-approved anticancer drugs. Using literature precedence, nine molecular descriptors were examined: molecular weight, number of chiral centers, number of rotatable bonds, number of acceptor atoms for H-bonds (N,O,F), number of donor atoms for H-bonds (N and O), topological polar surface area using N,O polar contributions, Moriguchi octanol-water partition coefficient, number of nitrogen atoms, and number of oxygen atoms. Four principal components explained 87% of the variation found among 343 bioactive natural products and 96 FDA-approved anticancer drugs. Across the four dimensions, fungal, cyanobacterial and plant isolates occupied both similar and distinct areas of chemical space that collectively aligned well with FDA-approved anticancer agents. Thus, examining three separate re-sources for anticancer drug leads yields compounds that probe chemical space in a complementary fashion.

  16. Circular of the Ministry of Commerce on Further Improving Examination and Approval of Foreign Investment

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    @@ Competent commercial authorities of provinces,autonomous regions,municipalities directly under the Central Government,separately planning cities, arbin, Changchun, Shenyang, Jinan, Nanjing, Hangzhou, Guangzhou, Wuhan, Chengdu, Xi'an and Xingjiang Production and Construction Corps,national economic and technological development zones,and national border economic cooperation zones,For the purpose of carrying out the scientific outlook on development,and according to the requirements of the important spirits of the Second Plenary Session of the 17th Central Committee of the Communist Party of China and the State Council on promoting the reform of the administrative system of examination and approval and constructing service-oriented government,the Ministry of Commcrce will,based on expanding domestic demand and maintaining the stable and rapid growth of Chinese economy,determine to continuously deepen the reform of the administrative system of examination and approval of foreign investment and further expand the administrative authority for examination and approval of foreign investment of local competent commercial authorities and national economic and technological development zones.

  17. 77 FR 40069 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

    Science.gov (United States)

    2012-07-06

    ... drug products are new drugs that require approved new drug applications (NDAs) or abbreviated new drug.... Unapproved new drug products containing oxycodone pose particular safety concerns because of their...

  18. Patentability potential of natural products for xerostomia treatment

    OpenAIRE

    2016-01-01

    Xerostomia is characterized as a symptom caused by hyposalivation, which can occur for reasons such as age, polypharmacy, radiation therapy, among others. Currently,few products are available for the treatment of xerostomia, which is a subject still underestimated by many health professionals. Thus, we searched patents applied and approved in Brazil on xerostomia, to verify the existing innovation involving natural products. We found 33 patents applied and approved in Brazil, many of them usi...

  19. 24 CFR 990.145 - Dwelling units with approved vacancies.

    Science.gov (United States)

    2010-04-01

    ... and anti-crime initiatives. (b) On a project-by-project basis, subject to prior HUD approval and for... resulting from project modernization or unit modernization (such as work necessary to reoccupy vacant...

  20. Clean Water Act Approved Total Maximum Daily Load (TMDL) Documents

    Data.gov (United States)

    U.S. Environmental Protection Agency — Information from Approved and Established TMDL Documents as well as TMDLs that have been Withdrawn. This includes the pollutants identified in the TMDL Document, the...

  1. 49 CFR 178.74 - Approval of MEGCs.

    Science.gov (United States)

    2010-10-01

    ... this chapter +to obtain approval of a new design. When a series of MEGCs is manufactured without change... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR...

  2. 40 CFR 35.940-3 - Costs allowable, if approved.

    Science.gov (United States)

    2010-07-01

    ... of compost residues which result from wastewater treatment, if EPA has approved a program for use of the compost. (d) Acquisition of an operable portion of a treatment works. This type of acquisition...

  3. 46 CFR 160.054-7 - Procedure for approval.

    Science.gov (United States)

    2010-10-01

    ... fully the construction, material specification, arrangement, and list of contents to the Commander of... the first-aid kit. At the time of selection of the pre-approval sample, the manufacturer shall...

  4. 75 FR 60617 - Review and Approval of Projects

    Science.gov (United States)

    2010-10-01

    ... fracking water. Also, people farther than a half mile may experience impacts to their water, air, and soil... fracking activity. Response: The Commission can find no evidence linking its approval of water...

  5. 34 CFR 668.144 - Application for test approval.

    Science.gov (United States)

    2010-07-01

    ... distribution of test scores for each edition, form, level, sub-test, or partial battery, for which approval is....147; (5) Documentation of test development, including a history of the test's use; (6) Norming...

  6. The Facts on Bipolar Disorder and FDA-Approved Treatments

    Science.gov (United States)

    ... Home For Consumers Consumer Updates The Facts on Bipolar Disorder and FDA-Approved Treatments Share Tweet Linkedin ... to top What to Do if You Suspect Bipolar Disorder If you suspect you have a bipolar ...

  7. 78 FR 59711 - Renewal of Approved Information Collection

    Science.gov (United States)

    2013-09-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Bureau of Land Management Renewal of Approved Information Collection AGENCY: Bureau of Land Management... Management, Information Collection Clearance Officer. BILLING CODE 4310-84-P...

  8. Living with Fibromyalgia, Drugs Approved to Manage Pain

    Science.gov (United States)

    ... Consumers Home For Consumers Consumer Updates Living with Fibromyalgia, Drugs Approved to Manage Pain Share Tweet Linkedin ... syndrome, and depression. back to top What Causes Fibromyalgia? Scientists believe that the condition may be due ...

  9. 78 FR 2315 - Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2013-01-10

    ...: Kupetsky, ABR-201211010, Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd..., Nicholson Township, Wyoming County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: November...

  10. 9 CFR 317.4 - Labeling approval.

    Science.gov (United States)

    2010-01-01

    ... is a printer's proof or equivalent which clearly shows all labeling features, size, location, and... carcass ink brands and meat food product ink and burning brands, which comply with parts 312 and 316...

  11. Colloidal Silver Not Approved for Treating Animals

    OpenAIRE

    Bagley, Clell

    1997-01-01

    FDA has received reports that products containing colloidal silver are being promoted for use in the treatment of mastitis and other serious disease conditions of dairy cattle, as well as for various conditions of companion animals. For example, FDA’s Center for Veterinary Medicine has received reports from the Agency's regional milk specialists and State inspectors that colloidal silver products have been found on some dairy farms. Also, recent articles in some farm newspapers and journals p...

  12. 7 CFR 1427.1086 - Approval of warehouse, requests for reconsideration.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 10 2010-01-01 2010-01-01 false Approval of warehouse, requests for reconsideration... Standards for Approval of Warehouses for Cotton and Cotton Linters § 1427.1086 Approval of warehouse, requests for reconsideration. (a) CCC will approve a warehouse if it determines that the warehouse...

  13. 30 CFR 285.614 - When may I begin conducting activities under my approved SAP?

    Science.gov (United States)

    2010-07-01

    ... approved SAP? 285.614 Section 285.614 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE... Plans and Information Requirements Activities Under An Approved Sap § 285.614 When may I begin conducting activities under my approved SAP? (a) You may begin conducting the activities approved in your...

  14. 21 CFR 314.153 - Suspension of approval of an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Suspension of approval of an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA... new drug application. (a) Suspension of approval. The approval of an abbreviated new drug...

  15. 10 CFR 52.145 - Finality of standard design approvals; information requests.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Finality of standard design approvals; information... approvals; information requests. (a) An approved design must be used by and relied upon by the NRC staff and... compliance with the current licensing basis of the standard design approval, information requests to...

  16. 77 FR 21453 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to New Source...

    Science.gov (United States)

    2012-04-10

    ... and 2.. notice. A-I.B.10 D-II.A.5 Baseline Area Yes 51.166(b)(15)..... Approved by Fully approved... D-VIII Area Yes, with the 51.166(e)......... Approved by Fully approved * * Classifications... modified sources impacting attainment and non-attainment areas in the State. This action is being...

  17. 42 CFR 84.36 - Delivery of changed or modified approved respirator.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Delivery of changed or modified approved respirator... Approval and Disapproval § 84.36 Delivery of changed or modified approved respirator. An approved respirator for which a formal certificate of modification has been issued shall be delivered, with...

  18. 75 FR 65551 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2010-10-25

    ... Authority, Wichita, Kansas. Application Number: 10-07-C-00-ICT. Application Type: Impose and use a PFC. PFC... Disapprovals. In September 2010, there were four applications approved. This notice also includes information on seven applications, one approved in May 2009, two approved in July 2010, and four approved...

  19. Radiochemical analyses of several spent fuel Approved Testing Materials

    Energy Technology Data Exchange (ETDEWEB)

    Guenther, R.J.; Blahnik, D.E.; Wildung, N.J.

    1994-09-01

    Radiochemical characterization data are described for UO{sub 2} and UO{sub 2} plus 3 wt% Gd{sub 2}O{sub 3} commercial spent nuclear fuel taken from a series of Approved Testing Materials (ATMs). These full-length nuclear fuel rods include MLA091 of ATM-103, MKP070 of ATM-104, NBD095 and NBD131 of ATM-106, and ADN0206 of ATM-108. ATMs 103, 104, and 106 were all irradiated in the Calvert Cliffs Nuclear Power Plant (Reactor No.1), a pressurized-water reactor that used fuel fabricated by Combustion Engineering. ATM-108 was part of the same fuel bundle designed as ATM-105 and came from boiling-water reactor fuel fabricated by General Electric and irradiated in the Cooper Nuclear Power Plant. Rod average burnups and expected fission gas releases ranged from 2,400 to 3,700 GJ/kgM. (25 to 40 Mwd/kgM) and from less than 1% to greater than 10%, respectively, depending on the specific ATM. The radiochemical analyses included uranium and plutonium isotopes in the fuel, selected fission products in the fuel, fuel burnup, cesium and iodine on the inner surfaces of the cladding, {sup 14}C in the fuel and cladding, and analyses of the gases released to the rod plenum. Supporting examinations such as fuel rod design and material descriptions, power histories, and gamma scans used for sectioning diagrams are also included. These ATMs were examined as part of the Materials Characterization Center Program conducted at Pacific Northwest Laboratory provide a source of well-characterized spent fuel for testing in support of the US Department of Energy Office of Civilian Radioactive Waste Management Program.

  20. 78 FR 68997 - Approval and Promulgation of Implementation Plans; Florida; Approval of Revision to the State...

    Science.gov (United States)

    2013-11-18

    ... Organic Fiber Production.'' EPA has determined that this provision was erroneously incorporated into the....) entitled ``Synthetic Organic Fiber Production'' was inadvertently incorporated into the Florida SIP on June... synthetic organic fiber production facilities in northwest Florida. The rule was only concerned...

  1. 7 CFR 58.222 - Dry dairy product cooling equipment.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Dry dairy product cooling equipment. 58.222 Section 58... DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection and Grading Service 1 Equipment and Utensils § 58.222 Dry dairy product cooling equipment. Cooling equipment shall...

  2. 21 CFR 814.19 - Product development protocol (PDP).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Product development protocol (PDP). 814.19 Section...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES General § 814.19 Product development protocol (PDP). A class III device for which a product development protocol has been declared completed by FDA...

  3. Discrimination of approved drugs from experimental drugs by learning methods

    Directory of Open Access Journals (Sweden)

    Li Yixue

    2011-05-01

    Full Text Available Abstract Background To assess whether a compound is druglike or not as early as possible is always critical in drug discovery process. There have been many efforts made to create sets of 'rules' or 'filters' which, it is hoped, will help chemists to identify 'drug-like' molecules from 'non-drug' molecules. However, among the chemical space of the druglike molecules, the minority will be approved drugs. Classifying approved drugs from experimental drugs may be more helpful to obtain future approved drugs. Therefore, discrimination of approved drugs from experimental ones has been done in this paper by analyzing the compounds in terms of existing drugs features and machine learning methods. Results Four methodologies were compared by their performance to classify approved drugs from experimental ones. The best results were obtained by SVM, in which the accuracy is 0.7911, the sensitivity is 0.5929, and the specificity is 0.8743. Based on the results, consensus model was developed to effectively discriminate drugs, which further pushed the correct classification rate up to 0.8517, sensitivity up to 0.7242, specificity up to 0.9352. The applications on the Traditional Chinese Medicine Ingredients Database (TCM-ID tested the methods. Therefore this model has been proven to be a potent tool for identifying drug molecules. Conclusion The studies would have potential applications in the research of combinatorial library design and virtual high throughput screening for drug discovery.

  4. PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs.

    Science.gov (United States)

    Turecek, Peter L; Bossard, Mary J; Schoetens, Freddy; Ivens, Inge A

    2016-02-01

    Modification of biopharmaceutical molecules by covalent conjugation of polyethylene glycol (PEG) molecules is known to enhance pharmacologic and pharmaceutical properties of proteins and other large molecules and has been used successfully in 12 approved drugs. Both linear and branched-chain PEG reagents with molecular sizes of up to 40 kDa have been used with a variety of different PEG derivatives with different linker chemistries. This review describes the properties of PEG itself, the history and evolution of PEGylation chemistry, and provides examples of PEGylated drugs with an established medical history. A trend toward the use of complex PEG architectures and larger PEG polymers, but with very pure and well-characterized PEG reagents is described. Nonclinical toxicology findings related to PEG in approved PEGylated biopharmaceuticals are summarized. The effect attributed to the PEG part of the molecules as observed in 5 of the 12 marketed products was cellular vacuolation seen microscopically mainly in phagocytic cells which is likely related to their biological function to absorb and remove particles and macromolecules from blood and tissues. Experience with marketed PEGylated products indicates that adverse effects in toxicology studies are usually related to the active part of the drug but not to the PEG moiety.

  5. 21 CFR 314.107 - Effective date of approval of a 505(b)(2) application or abbreviated new drug application under...

    Science.gov (United States)

    2010-04-01

    ... introduction into interstate commerce when approval of the application or abbreviated application for the drug... for 5 years of exclusive marketing under § 314.108(b)(2) and the patent owner or its representative or... application first commences commercial marketing of its drug product; or (ii) The date of a decision of...

  6. The System of Textbook Approval in Poland under Communist Rule (1944-1989) as a Tool of Power of the Regime

    Science.gov (United States)

    Wojdon, Joanna

    2015-01-01

    This paper analyses the process of production and regulation of school textbooks in Poland under communist rule. The stages of textbook approval were as follows: selection of authors; editorial work at the publishing house; discussions in the commissions of the Ministry of Education; decisions of the censorship office. It is argued that the Polish…

  7. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

    While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

  8. REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    D.W. Markman

    1999-09-17

    Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control

  9. Duchenne muscular dystrophy drugs face tough path to approval.

    Science.gov (United States)

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021.

  10. 21 CFR 310.540 - Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach...

    Science.gov (United States)

    2010-04-01

    ... is required for marketing. In the absence of an approved new drug application, such product is also... regulation, any such OTC drug product initially introduced or initially delivered for introduction...

  11. 21 CFR 310.532 - Drug products containing active ingredients offered over-the-counter (OTC) to relieve the...

    Science.gov (United States)

    2010-04-01

    ... chapter is required for marketing. In the absence of an approved application, such product is also..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  12. Need for Approval and Children's Well-Being

    OpenAIRE

    Rudolph, Karen D.; Caldwell, Melissa S.; CONLEY, COLLEEN S.

    2005-01-01

    This research examined the hypothesis that a tendency to base one's self-worth on peer approval is associated with positive and negative aspects of children's well-being. 153 4th - 8th graders (9.0 to 14.8 years) reported on need for approval (NFA), global self-worth, social-evaluative concerns, anxiety and depression, and exposure to victimization. Teachers reported on social behavior. Results confirmed that NFA is a two-dimensional construct composed of positive (enhanced self-worth in the ...

  13. Ethics approval: a challenge for public health researchers in India.

    Science.gov (United States)

    Nagaraja, Sharath Burugina; Menezes, Ritesh G; Zachariah, Rony; Wilson, Nevin

    2015-01-01

    There is increasing impetus, interest and opportunity for people working in public health programmes in India to carry out operational research (OR) around relevant programme issues and then publish that in peer-reviewed publications. These published researches are valuable in analysing, documenting and advocating for locally generated evidence to inform policy and practice. Ethics review and approval is an essential step in the process of OR but is often viewed as a barrier rather than a prerequisite of good practice in OR. Journals and peer reviewers are also increasingly requiring approvals from local institutional ethics committees (IECs).

  14. What do oncologists need to know about biosimilar products?

    OpenAIRE

    Leung, Linda K. S.; Mok, Kevin; Liu, Calvin; Chan, Stephen L.

    2016-01-01

    Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of “comparability” or “no clinically meaningful differences” as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colony-stimulating factor, trastuzumab,...

  15. Basic substances under EC 1107/2009 phytochemical regulation: experience with non-biocide and food products as biorationals

    Directory of Open Access Journals (Sweden)

    Marchand Patrice A.

    2016-07-01

    Full Text Available Basic Substances are a newly effective category of Plant Protection Product under EC Regulation No 1107/2009. The first approved application of Equisetum arvense L. opened Part C of Implementing Regulation (EU No 540/2011, which lists the basic substance approved. Although E. arvense was described as a fungicide extract, subsequent applications like chitosan were related to non-biocide molecules. Consequently, plant protection product data were collected from research on alternative or traditional crop protection methods. They are notably issued or derived from foodstuffs (plants, plant by-products, plant derived products, substances and derived substances from animal origin. Applications are currently submitted by our Institute, under evaluation at different stages of the approval process or already approved. Remarkably, this Basic Substance category under pesticide EU Regulation was surprisingly designed for these non-biocidal plant protection products. In fact, components described as the “active substance” of most of the actual applications are food products like sugars and lecithin. Basic Substance applications for these foodstuffs are therefore a straightforward way of easily gaining approval for them. Here we describe the approval context and detail the agricultural uses of theses food products as Biological Control Agents (BCAs or biorationals for crop protection. From all deposited or approved Basic Substance Application (BSA, a proof has been provided that non-biocide and food products via physical barrier or lure effects may be effective plant protection products with an acceptable low profile of concern for public and agricultural safety.

  16. 78 FR 35599 - Approval and Promulgation of Implementation Plans; Florida; Approval of Revision to the State...

    Science.gov (United States)

    2013-06-13

    ... Florida to remove a provision entitled ``Synthetic Organic Fiber Production.'' EPA has determined that..., 1992, SIP did not include a revision to incorporate the rule entitled ``Synthetic Organic Fiber...) Requirements The rule entitled ``Synthetic Organic Fiber Production,'' 62- 296.413, was originally...

  17. 78 FR 21171 - International Mail Product

    Science.gov (United States)

    2013-04-09

    ... International Business Reply Service (IBRS) Competitive Contract 3 negotiated service agreement (Agreement).\\1... Docket Nos. MC2011-21 and CP2011-59, Order No. 684, Order Approving International Business Reply Service... International Mail Product AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission...

  18. 78 FR 21633 - International Mail Product

    Science.gov (United States)

    2013-04-11

    ... International Business Reply Service (IBRS) Competitive Contract 3 negotiated service agreement (Agreement).\\1... Docket Nos. MC2011-21 and CP2011-59, Order No. 684, Order Approving International Business Reply Service... International Mail Product AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission...

  19. Pharmacovigilance of biologicals : dynamics in post-approval safety learning

    NARCIS (Netherlands)

    Vermeer, N.S.

    2015-01-01

    Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict inclusio

  20. 15 CFR 280.101 - Petitions for approval of documents.

    Science.gov (United States)

    2010-01-01

    ... requirements for the certification of manufacturing systems as fastener quality assurance systems by an..., shall approve such petition if the document provides equal or greater rigor and reliability as compared... information to allow the Director, NIST, to make this determination. (b) Accreditation. (1) A...

  1. 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...

  2. [Lake Mason and Soo Line Marsh project design approval

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This letter is the approval from the U.S. Fish and Wildlife Service of the designs created by Ducks Unlimited, Inc. for the Lake Mason and Soo Line Marsh National...

  3. Approval and Disapproval of Textbooks in the Late Ottoman Empire

    Science.gov (United States)

    Açikgöz, Betül

    2017-01-01

    During the rapidly changing political atmosphere of the 1910s, the practice of sanctioning scholastic knowledge began to be implemented in the yearly selection of textbooks due to political contingencies. The study shows the procedures of approval and disapproval practised by the Grand Council of Education and the Copyright and Translation Office…

  4. 21 CFR 1004.6 - Approval of plans.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of plans. 1004.6 Section 1004.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) RADIOLOGICAL... person who contests denial of a plan shall have an opportunity for a regulatory hearing before the...

  5. 36 CFR 9.37 - Plan of operations approval.

    Science.gov (United States)

    2010-07-01

    ..., natural catastrophe, acts of God, etc., for inspection shall not be included when computing either this... determination regarding the impact of this operation and cumulative impacts of all proposed and existing... Preservations Act of 1966 as implemented by 36 CFR part 800. (f) Approval of each plan of operations...

  6. 42 CFR 403.318 - Approval of State systems.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Approval of State systems. 403.318 Section 403.318 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS SPECIAL PROGRAMS AND PROJECTS Recognition of State Reimbursement Control Systems §...

  7. 29 CFR 1952.104 - Final approval determination.

    Science.gov (United States)

    2010-07-01

    ... dam construction projects; and private sector maritime employment on or adjacent to navigable waters... Final approval determination. (a) In accordance with Section 18(e) of the Act and procedures in 29 CFR... exception of temporary labor camps in agriculture, general industry, construction and logging) is at...

  8. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  9. 7 CFR 1822.273 - Actions subsequent to loan approval.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE LOANS AND GRANTS PRIMARILY FOR REAL ESTATE PURPOSES RURAL HOUSING LOANS AND GRANTS Rural Housing... 1822.273 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE.... After the loan is approved, actions to be taken will be in accordance with 7 CFR part 3560, subpart B....

  10. Endoscopy: consensus on approving propofol sedation by nonanesthesiologists.

    Science.gov (United States)

    Riphaus, Andrea

    2010-04-01

    Propofol sedation by nonanesthesiologists is still a highly controversial issue despite the fact that numerous studies have approved this sedation regimen for gastrointestinal endoscopy. A new position statement from a collaboration of four different American gastroenterology and hepatology societies outlines the latest recommendations for nonanesthesiologist administration of propofol.

  11. 10 CFR 725.15 - Requirements for approval of applications.

    Science.gov (United States)

    2010-01-01

    ... engaged in a substantial effort to develop, design, build or operate a chemical processing plant or other... Secret Restricted Data in C-91, Nuclear Reactors for Rocket Propulsion, will be approved only if the... capable of making a contribution to research and development in the field of nuclear reactors for...

  12. 33 CFR 157.12g - Plan approval requirements.

    Science.gov (United States)

    2010-07-01

    ... things, the location and mounting of components, arrangements for maintaining the integrity of the... manufacturer's specific installation criteria. (g) A copy of the certificate of type approval for the oil... system and confirming the installation reflects the manufacturer's specific installation criteria....

  13. Experts Approve Development of A Micro-DAFC System

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ Proposed research into a micro-power system for a direct alcohol fuel cell (DAFC)was approved by a panel of experts at an evaluation meeting held under the auspices of the CAS Bureau of High-tech Development on Oct. 28 in Dalian, Northeast China's Liaoning Province.

  14. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Science.gov (United States)

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  15. 21 CFR 314.125 - Refusal to approve an application.

    Science.gov (United States)

    2010-04-01

    ... (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications... study that is described in the application and that is essential to show that the drug is safe for use... adequately protected. (17) The applicant or contract research organization that conducted a...

  16. 29 CFR 500.160 - Approved State plans.

    Science.gov (United States)

    2010-07-01

    ... accordance with 29 CFR part 70. (c) Every enumerated delegated function shall be valid in all states. ... 29 Labor 3 2010-07-01 2010-07-01 false Approved State plans. 500.160 Section 500.160 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT...

  17. 45 CFR 95.611 - Prior approval conditions.

    Science.gov (United States)

    2010-10-01

    ... at the enhanced matching rate authorized by 45 CFR 205.35, 45 CFR part 307 or 42 CFR part 433...) Automatic Data Processing Equipment and Services-Conditions for Federal Financial Participation (FFP) Specific Conditions for Ffp § 95.611 Prior approval conditions. (a) General acquisition requirements. (1)...

  18. 19 CFR 134.45 - Approved markings of country name.

    Science.gov (United States)

    2010-04-01

    ... OF THE TREASURY COUNTRY OF ORIGIN MARKING Method and Location of Marking Imported Articles § 134.45 Approved markings of country name. (a) Language. (1) Except as otherwise provided in paragraph (a)(2) of this section, the markings required by this part shall include the full English name of the country...

  19. 46 CFR 160.077-6 - Approval procedures.

    Science.gov (United States)

    2010-10-01

    ... PFD of sufficiently similar design. (2) Engineering analysis showing that the test is not applicable...) Alternative Requirements. A PFD that does not meet requirements in this subpart may still be approved if the device— (1) Meets other requirements prescribed by the Commandant in place of or in addition...

  20. 30 CFR 75.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... conductors are a part of the system will be approved if a solid connection is made to the neutral conductor... low resistance to earth; (c) A solid connection to a grounding conductor, other than the neutral conductor of a resistance grounded system, extending to a low resistance ground field located on the...

  1. 30 CFR 77.700-1 - Approved methods of grounding.

    Science.gov (United States)

    2010-07-01

    ... in resistance grounded systems, where the enclosed conductors are a part of the system, will be approved if a solid connection is made to the neutral conductor; in all other systems, the following... earth; (b) A solid connection to a grounding conductor, other than the neutral conductor of a...

  2. 44 CFR 78.6 - Flood Mitigation Plan approval process.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Flood Mitigation Plan..., DEPARTMENT OF HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program FLOOD MITIGATION ASSISTANCE § 78.6 Flood Mitigation Plan approval process. The State POC will forward all...

  3. Psychodiagnostic Testing in APA-Approved Clinical Psychology Programs.

    Science.gov (United States)

    Piotrowski, Chris; Keller, John W.

    The utility and popularity of psychodiagnostic testing has been investigated in applied clinical settings, but little data exist concerning academicians' attitudes toward psychological testing. To assess attitudes toward psychodiagnostic training in doctoral, clinical psychology programs, all fully APA-approved (American Psychological Association)…

  4. Interview with Robert Coffin, inventor of T-VEC: the first oncolytic immunotherapy approved for the treatment of cancer.

    Science.gov (United States)

    Coffin, Robert

    2016-02-01

    Interviewed by Ellen Clarke, Commissioning Editor, Future Science Group. Robert Coffin is co-founder and CEO of Replimune. Previously he was Founder and CTO of BioVex Inc, a spin out from his research group at University College London in 1999. He was the inventor of all BioVex products including OncoVEXGM-CSF (talimogene laherparepvec; T-VEC; Imlygic) and oversaw all research and clinical development including bringing T-VEC through to two pivotal Phase 3 studies in melanoma and head and neck cancer. BioVex was acquired by Amgen in 2011 where he was VP Global Development until 2013. T-VEC was approved by the FDA for use in advanced melanoma in October 2015, the first oncolytic therapy or gene therapy to be approved in USA. He was awarded a PhD in virology from Imperial College London prior to his move to University College London in 1991.

  5. Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

    Science.gov (United States)

    Hollander, Ilyssa

    2006-02-01

    In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.

  6. 77 FR 15367 - Public Water System Supervision Program Approval for the State of Minnesota

    Science.gov (United States)

    2012-03-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Minnesota AGENCY: Environmental... of Minnesota is revising its approved public water system supervision program for four major...

  7. 77 FR 21099 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-04-09

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved three revisions to the State of Ohio's public water system supervision... of Ohio's public water system supervision program, thereby giving Ohio EPA primary...

  8. 78 FR 18336 - Public Water System Supervision Program Approval for the State of Michigan

    Science.gov (United States)

    2013-03-26

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Michigan AGENCY: Environmental... has tentatively approved five revisions to the State of Michigan's public water system...

  9. 77 FR 76034 - Public Water System Supervision Program Approval for the State of Ohio

    Science.gov (United States)

    2012-12-26

    ... AGENCY Public Water System Supervision Program Approval for the State of Ohio AGENCY: Environmental... has tentatively approved revisions to the State of Ohio's public water system supervision program... public water system supervision program, thereby giving Ohio EPA primary enforcement responsibility...

  10. 78 FR 14791 - Public Water System Supervision Program Approval for the State of Indiana

    Science.gov (United States)

    2013-03-07

    ... AGENCY Public Water System Supervision Program Approval for the State of Indiana AGENCY: Environmental... has tentatively approved three revisions to the State of Indiana's public water system supervision... the State of Indiana's public water system supervision program, thereby giving IDEM...

  11. 75 FR 80493 - Public Water System Supervision Program Approval for the State of Wisconsin

    Science.gov (United States)

    2010-12-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Wisconsin AGENCY: Environmental... of Wisconsin submitted a primacy application for its approved Public Water System Supervision...

  12. When your words count: a discriminative model to predict approval of referrals

    Directory of Open Access Journals (Sweden)

    Adol Esquivel

    2009-12-01

    Conclusions Three iterations of the model correctly predicted at least 75% of the approved referrals in the validation set. A correct prediction of whether or not a referral will be approved can be made in three out of four cases.

  13. 21 CFR 314.105 - Approval of an application and an abbreviated application.

    Science.gov (United States)

    2010-04-01

    ... labeling prior to marketing. (c) FDA will approve an application after it determines that the drug meets... not be introduced or delivered for introduction into interstate commerce until approval of...

  14. 77 FR 6535 - Notice of Intent To Seek Approval To Collect Information

    Science.gov (United States)

    2012-02-08

    ... National Agricultural Library Notice of Intent To Seek Approval To Collect Information AGENCY: National... extend currently approved data collection form. Abstract: This Web-based form collects information to.... Information collected includes the following: Preference of workshop date, signature, name,...

  15. 76 FR 70807 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Science.gov (United States)

    2011-11-15

    ... emergency radio dispatch system is used for both eligible (aircraft rescue and firefighting and aviation... Federal Aviation Administration Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Monthly notice of PFC approvals...

  16. 45 CFR 1801.31 - Approval of graduate programs by the Foundation.

    Science.gov (United States)

    2010-10-01

    ... approval. The graduate program proposed for approval may differ from that proposed by the Scholar when... statement of interest in a career in public service that specifies in detail how their graduate program...

  17. 75 FR 71177 - Notice of Projects Approved for Consumptive Uses of Water

    Science.gov (United States)

    2010-11-22

    ... From the Federal Register Online via the Government Publishing Office SUSQUEHANNA RIVER BASIN COMMISSION Notice of Projects Approved for Consumptive Uses of Water AGENCY: Susquehanna River Basin... notice lists the projects, described ] below, receiving approval for the consumptive use of...

  18. 77 FR 24441 - Approval and Promulgation of Implementation Plans; California; Revisions to the California State...

    Science.gov (United States)

    2012-04-24

    ... Ninth Circuit Court of Appeals of EPA's 2009 approval of a revision to the California SIP related to..., the 9th Circuit Court of Appeals remanded the approval of PEST-1 to EPA with the instructions...

  19. 78 FR 56225 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...

    Science.gov (United States)

    2013-09-12

    ... AGENCY Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Soil...) for review and approval in accordance with the Paperwork Reduction Act: ``Soil Fumigant Risk... measures necessary for reregistration eligibility for certain soil fumigant chemicals are...

  20. 48 CFR 45.606-2 - Contractor without an approved scrap procedure.

    Science.gov (United States)

    2010-10-01

    ... approved scrap procedure. 45.606-2 Section 45.606-2 Federal Acquisition Regulations System FEDERAL... Contractor without an approved scrap procedure. The contractor shall submit an inventory disposal schedule for all scrap....

  1. 75 FR 32355 - Notice of Request for Revision of a Currently Approved Information Collection

    Science.gov (United States)

    2010-06-08

    ... Agricultural Marketing Service Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY: In... Agricultural Marketing Service's (AMS) intention to request for revision of a currently approved...

  2. 78 FR 54232 - Notice of Request for Extension of a Currently Approved Information Collection

    Science.gov (United States)

    2013-09-03

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service Notice of Request for Extension of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request... that the Agricultural Marketing Service (AMS) is requesting approval from the Office of Management...

  3. 42 CFR 488.61 - Special procedures for approval and re-approval of organ transplant centers.

    Science.gov (United States)

    2010-10-01

    ... described at 42 CFR part 488, subpart A apply to transplant centers, including the periodic review of... are not Medicare-approved as of June 28, 2007. A transplant center, including a kidney transplant... Report and 1-year patient and graft survival data contained in the most recent Scientific Registry...

  4. 78 FR 41311 - Approval of Air Quality Implementation Plans; Indiana; Approval of “Infrastructure” SIP With...

    Science.gov (United States)

    2013-07-10

    ... Business Information or other information whose disclosure is restricted by statute. Certain other material.... FOR FURTHER INFORMATION CONTACT: Andy Chang, Environmental Engineer, Attainment Planning and... of IDEM's SIP-approved update to the definition of the 2006 PM 2.5 NAAQS? III. What action is...

  5. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

  6. Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater

    Science.gov (United States)

    2014-11-01

    Results of Shipboard Approval Tests of Ballast Water Treatment Systems in Freshwater Distribution Statement A: Approved for public release...distribution is unlimited. November 2014 Report No. CG-D-05-15 Results of Shipboard Approval Tests of BWT Systems in Freshwater ii...London, CT 06320 Results of Shipboard Approval Tests of BWT Systems in Freshwater iii UNCLAS//Public | CG-926 R&DC | Cangelosi, et al

  7. 7 CFR 319.8-11 - From approved areas of Mexico.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false From approved areas of Mexico. 319.8-11 Section 319.8... Conditions for the Entry of Cotton and Covers from Mexico § 319.8-11 From approved areas of Mexico. (a) Entry... in, and which were produced and handled only in approved areas of Mexico 5 may be authorized...

  8. 14 CFR 61.4 - Qualification and approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Qualification and approval of flight... GROUND INSTRUCTORS General § 61.4 Qualification and approval of flight simulators and flight training..., testing, or checking requirement under this chapter, must be qualified and approved by the...

  9. 7 CFR 4290.480 - Prior approval of changes to RBIC's business plan.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 15 2010-01-01 2010-01-01 false Prior approval of changes to RBIC's business plan... § 4290.480 Prior approval of changes to RBIC's business plan. Without the Secretary's prior written approval, no change in your business plan, upon which you were selected and licensed as a RBIC, may...

  10. 42 CFR 403.222 - State with an approved regulatory program.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false State with an approved regulatory program. 403.222 Section 403.222 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Programs § 403.222 State with an approved regulatory program. (a) A State has an approved...

  11. 42 CFR 403.308 - State systems under demonstration projects-mandatory approval.

    Science.gov (United States)

    2010-10-01

    ...-mandatory approval. 403.308 Section 403.308 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... Reimbursement Control Systems § 403.308 State systems under demonstration projects—mandatory approval. CMS will... approval of a State system are met under § 403.304 (b)(1)-(10) and § 403.304(c), and, if appropriate §...

  12. 28 CFR 2.206 - Travel approval and transfers of supervision.

    Science.gov (United States)

    2010-07-01

    ... supervision. 2.206 Section 2.206 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION... Supervised Releasees § 2.206 Travel approval and transfers of supervision. (a) A releasee's supervision officer may approve travel outside the district of supervision without approval of the Commission in...

  13. 7 CFR 330.210a - Administrative instructions listing approved packing materials for plant pests.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Administrative instructions listing approved packing... Pests § 330.210a Administrative instructions listing approved packing materials for plant pests. (a) The following materials are approved as packing materials for use with any shipment of plant pests in...

  14. 76 FR 61999 - Policy Statement: Inappropriate Design Approval Holder (DAH) Restrictions on the Use and...

    Science.gov (United States)

    2011-10-06

    ... Federal Aviation Administration 14 CFR Part 21 Policy Statement: Inappropriate Design Approval Holder (DAH... the proposed policy statement addressing the action taken by some Design Approval Holders (DAH...(b) requires the holder of a design approval to furnish at least one set of complete Instructions...

  15. 43 CFR 45.74 - Has OMB approved the information collection provisions of this subpart?

    Science.gov (United States)

    2010-10-01

    ... OMB approved the information collection provisions of this subpart? Yes. This rule contains provisions that would collect information from the public. It therefore requires approval by the Office of... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Has OMB approved the...

  16. 13 CFR 302.8 - Pre-approval Investment Assistance costs.

    Science.gov (United States)

    2010-01-01

    ..., DEPARTMENT OF COMMERCE GENERAL TERMS AND CONDITIONS FOR INVESTMENT ASSISTANCE § 302.8 Pre-approval Investment Assistance costs. Project activities carried out before approval of Investment Assistance shall be carried... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Pre-approval Investment...

  17. The Effect of Perceived Parental Approval of Drinking on Alcohol Use and Problems

    Science.gov (United States)

    Messler, Erick C.; Quevillon, Randal P.; Simons, Jeffrey S.

    2014-01-01

    The relationship between perceived parental approval of drinking and alcohol use and problems was explored with undergraduate students in a small midwestern university. Participants completed a survey measuring demographic information, perceived approval of drinking, and alcohol use and problems. Results indicated perceived parental approval of…

  18. 34 CFR 668.143 - Approval of State tests or assessments.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Approval of State tests or assessments. 668.143 Section... or assessments. (a) The Secretary approves tests or other assessments submitted by a State that the... assessment described in paragraph (a) of this section. (c) If the Secretary approves a State's tests...

  19. 14 CFR 125.297 - Approval of flight simulators and flight training devices.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Approval of flight simulators and flight... Flight Crewmember Requirements § 125.297 Approval of flight simulators and flight training devices. (a) Flight simulators and flight training devices approved by the Administrator may be used in...

  20. 78 FR 57903 - Notice of Intent To Seek Approval To Renew an Information Collection

    Science.gov (United States)

    2013-09-20

    ... From the Federal Register Online via the Government Publishing Office NATIONAL SCIENCE FOUNDATION Notice of Intent To Seek Approval To Renew an Information Collection AGENCY: National Science Foundation.... Expiration Date of Approval: June 30, 2014. Type of Request: Intent to seek approval to renew an...

  1. 17 CFR 240.14a-20 - Shareholder approval of executive compensation of TARP recipients.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Shareholder approval of... § 240.14a-20 Shareholder approval of executive compensation of TARP recipients. If a solicitation is... shareholder vote to approve the compensation of executives, as disclosed pursuant to Item 402 of Regulation...

  2. 14 CFR 414.31 - Monitoring compliance with the terms and conditions of a safety approval.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Monitoring compliance with the terms and conditions of a safety approval. 414.31 Section 414.31 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety Approval Review and Issuance §...

  3. 21 CFR 900.3 - Application for approval as an accreditation body.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Application for approval as an accreditation body... approval as an accreditation body. (a) Eligibility. Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accreditation bodies....

  4. 75 FR 71135 - Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug Application

    Science.gov (United States)

    2010-11-22

    ... HUMAN SERVICES Food and Drug Administration Hoffmann-La Roche Inc.; Withdrawal of Approval of a New Drug... Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules... be marketed under approved abbreviated new drug applications (ANDAs). The holders of ANDAs...

  5. 21 CFR 314.127 - Refusal to approve an abbreviated new drug application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Refusal to approve an abbreviated new drug... HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.127 Refusal to approve an abbreviated new...

  6. 42 CFR 422.256 - Review, negotiation, and approval of bids.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Review, negotiation, and approval of bids. 422.256... Information and Plan Approval § 422.256 Review, negotiation, and approval of bids. (a) Authority. Subject to... submitted under § 422.252 and conduct negotiations with MA organizations regarding these bids (including...

  7. 7 CFR 1717.613 - RUS approval of data processing and system control equipment.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false RUS approval of data processing and system control... system control equipment. If a borrower's mortgage or loan contract requires the borrower to obtain approval from RUS before purchasing data processing equipment or system control equipment, such approval...

  8. 25 CFR 1200.15 - What is the approval process for management plans?

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false What is the approval process for management plans? 1200... INTERIOR AMERICAN INDIAN TRUST FUND MANAGEMENT REFORM ACT Withdrawing Tribal Funds From Trust § 1200.15 What is the approval process for management plans? The Secretary will approve or disapprove...

  9. 33 CFR 175.21 - Condition; size and fit; approval marking.

    Science.gov (United States)

    2010-07-01

    ...; and (c) Legibly marked with its approval number, as specified in 46 CFR part 160. ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Condition; size and fit; approval...; size and fit; approval marking. No person may use a recreational boat unless each PFD required by §...

  10. 26 CFR 1.422-3 - Stockholder approval of incentive stock option plans.

    Science.gov (United States)

    2010-04-01

    ... 26 Internal Revenue 5 2010-04-01 2010-04-01 false Stockholder approval of incentive stock option... incentive stock option plans. This section addresses the stockholder approval of incentive stock option... such cases an incentive stock option plan must be approved: (a) By a majority of the votes cast at...

  11. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  12. 30 CFR 72.710 - Selection, fit, use, and maintenance of approved respirators.

    Science.gov (United States)

    2010-07-01

    ... approved respirators. 72.710 Section 72.710 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... Selection, fit, use, and maintenance of approved respirators. In order to ensure the maximum amount of respiratory protection, approved respirators shall be selected, fitted, used, and maintained in...

  13. 7 CFR 1710.209 - Approval requirements for load forecast work plans.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Approval requirements for load forecast work plans... LOANS AND GUARANTEES Load Forecasts § 1710.209 Approval requirements for load forecast work plans. (a... utility plant of $500 million or more must maintain an approved load forecast work plan. RUS...

  14. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at... 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... approval of NADA 008-019, and all supplements and amendments thereto, is hereby withdrawn. Elsewhere...

  15. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the.... Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... gave notice that approval of NADA 008-019, and all supplements and amendments thereto, is...

  16. 42 CFR 410.142 - CMS process for approving national accreditation organizations.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false CMS process for approving national accreditation... Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.142 CMS process for approving national accreditation organizations. (a) General rule. CMS may approve and recognize a nonprofit or...

  17. Use of Fixed Dose Combination (FDC Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, Metformin, or Psychotropic Drugs.

    Directory of Open Access Journals (Sweden)

    Patricia McGettigan

    2015-05-01

    Full Text Available In 2012, an Indian parliamentary committee reported that manufacturing licenses for large numbers of fixed dose combination (FDC drugs had been issued by state authorities without prior approval of the Central Drugs Standard Control Organization (CDSCO in violation of rules, and considered that some ambiguity until 1 May 2002 about states' powers might have contributed. To our knowledge, no systematic enquiry has been undertaken to determine if evidence existed to support these findings. We investigated CDSCO approvals for and availability of oral FDC drugs in four therapeutic areas: analgesia (non-steroidal anti-inflammatory drugs [NSAIDs], diabetes (metformin, depression/anxiety (anti-depressants/benzodiazepines, and psychosis (anti-psychotics.This was an ecologic study with a time-trend analysis of FDC sales volumes (2007-2012 and a cross-sectional examination of 2011-2012 data to establish the numbers of formulations on the market with and without a record of CDSCO approval ("approved" and "unapproved", their branded products, and sales volumes. Data from the CDSCO on approved FDC formulations were compared with sales data from PharmaTrac, a database of national drug sales. We determined the proportions of FDC sales volumes (2011-2012 arising from centrally approved and unapproved formulations and from formulations including drugs banned/restricted internationally. We also determined the proportions of centrally approved and unapproved formulations marketed before and after 1 May 2002, when amendments were made to the drug rules. FDC approvals in India, the United Kingdom (UK, and United States of America (US were compared. For NSAID FDCs, 124 formulations were marketed, of which 34 (27% were centrally approved and 90 (73% were unapproved; metformin: 25 formulations, 20 (80% approved, five (20% unapproved; anti-depressants/benzodiazepines: 16 formulations, three (19% approved, 13 (81% unapproved; anti-psychotics: ten formulations, three (30

  18. Cancer wars: Natural products strike back

    OpenAIRE

    Christine eBasmadjian; Qian eZhao; Amel eDjehal; Embarek eBentouhami; Nebigil, Canan G.; Johnson, Roger A.; Maria eSerova; Armand eDe Gramont; Sandrine eFaivre; Eric eRaymond; Désaubry, Laurent G.

    2014-01-01

    Natural products have historically been a mainstay source of anticancer drugs, but in the 90’s they fell out of favor in pharmaceutical companies with the emergence of targeted therapies, which rely on antibodies or small synthetic molecules identified by high throughput screening. Although targeted therapies greatly improved the treatment of a few cancers, the benefit has remained disappointing for many sol¬¬id tumors, which revitalized the interest in natural products. With the approval of ...

  19. Cancer wars: natural products strike back

    OpenAIRE

    Basmadjian, Christine; Zhao, Qian; Bentouhami, Embarek; Djehal, Amel; Nebigil, Canan G.; Johnson, Roger A.; Serova, Maria; Gramont, Armand de; Faivre, Sandrine; Raymond, Eric; Désaubry, Laurent G.

    2014-01-01

    Natural products have historically been a mainstay source of anticancer drugs, but in the 90's they fell out of favor in pharmaceutical companies with the emergence of targeted therapies, which rely on antibodies or small synthetic molecules identified by high throughput screening. Although targeted therapies greatly improved the treatment of a few cancers, the benefit has remained disappointing for many solid tumors, which revitalized the interest in natural products. With the approval of ra...

  20. 21 CFR 314.108 - New drug product exclusivity.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false New drug product exclusivity. 314.108 Section 314...) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG FDA Action on Applications and Abbreviated Applications § 314.108 New drug product exclusivity. (a) Definitions. The following definitions...

  1. 46 CFR 162.050-13 - Factory production and inspection.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Factory production and inspection. 162.050-13 Section....050-13 Factory production and inspection. (a) Equipment manufactured under Coast Guard approval must... any time to visit a factory where the equipment is manufactured to conduct an inspection of...

  2. 7 CFR 735.202 - Standards of grades for other agricultural products.

    Science.gov (United States)

    2010-01-01

    ... WAREHOUSE ACT Inspectors, Samplers, Classifiers, and Weighers § 735.202 Standards of grades for other... and grade of the agricultural product must be stated, subject to the approval of DACO. If...

  3. Farther Export Tariff Laid on Some RE Metallic Products

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ To further regulate the export of high-energy-consumption and high-pollution products and resources products, promote the import of energy products, resource products and key components and facilitate the trade balance, and approved by the 9th Meeting of Tariff Regulations Commission of the State Council, China would adjust the import and export tariff rate of some commodities since June 1st, 2007.

  4. Digital repositories certification: the Data Seal of Approval

    Directory of Open Access Journals (Sweden)

    Stefano Allegrezza

    2015-09-01

    Full Text Available In recent years, it has become increasingly common to entrust records to digital repositories; this assumes an implicit confidence in the repositories reliability, and therefore is urgent to identify the criteria on which to evaluate them. The Data Seal of Approval is a set of sixteen criteria that can be used to ensure that archived data can still be found, understood and used in the future. It is a basic level of certification but it is very useful to highlight the strengths and weaknesses of the deposit; in any case, it constitutes a solid basis for further certification of compliance to ISO 16363 or DIN 31644. The aim of this article is to provide an overview of Data Seal of Approval in the wider context of digital repositories' certification.

  5. INDACATEROL: A NEW APPROVED MOLECULE TO TREAT COPD

    Directory of Open Access Journals (Sweden)

    Jaithlia Rajiv

    2011-05-01

    Full Text Available Indacaterol approved as once-daily bronchodilator for chronic obstructive pulmonary disease (COPD. Indacaterol is a new molecular entity in the β2-adrenergic agonist class taken only once a day unlike the currently available β2-adrenergic agonist that helps relax muscles around lung airways to prevent COPD symptoms, such as wheezing and breathlessness. It is approved only for the treatment of chronic obstructive pulmonary disease (COPD (long-term data in patients with asthma are thus far lacking. It is delivered as an aerosol formulation through a dry powder inhaler. The most commonly reported side effects/adverse effects in patients taking Indacaterol (> 2% and more common than placebo are runny nose, cough, sore throat, headache, and nausea. The main benefit, it is Long Acting β2-adrenergic agonist (LABA, once in a day dosing is sufficient.

  6. Implications of Recent Drug Approvals for Older Adults

    Science.gov (United States)

    Eisenhower, Christine; Koronkowski, Michael; Marcum, Zachary

    2016-01-01

    More than 100 medications were approved by the US Food and Drug Administration as new drugs or for new indications in 2014 and 2015. Several of the new drugs may benefit older adults, but adverse events and pharmacokinetic changes due to aging must be considered. This article will focus on three recently approved drugs that are marketed for chronic conditions that can affect older adults: suvorexant, for treatment of insomnia; edoxaban, for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for treatment of venous thromboembolism; and droxidopa, for treatment of symptomatic neurogenic orthostatic hypotension. Information about indications, mechanisms of action, dosing, efficacy, and safety are reviewed. The place of each agent in therapy for older adults is also discussed. PMID:27340374

  7. Organization of regulatory instruments. Close-ups of energy agreements and environmental approvals; Organisering af styringsinstrumenter. Naerbilleder af energiaftaler og miljoegodkendelser

    Energy Technology Data Exchange (ETDEWEB)

    Holm Pedersen, L.; Rieper, O.; Hansen, P.

    1998-12-01

    Energy agreements were introduced in the 1990s as a tool which, via a central authority and integrated use of consultants, was intended to get the companies in question to improve their energy efficiency and thus reduce their impact on the environment in the form of CO{sub 2} emissions. The agreements give companies with energy-intensive production the possibility of achieving a reduction of their energy tax by entering into an agreement with the Danish Energy Agency. The agreements are, in principle, voluntary, but are often an economic `must` for the companies. Unlike energy agreements, environmental approvals are obligatory for certain types of companies and are granted by a local authority (county or municipality), which supervises compliance with the approvals. The approvals include requirements concerning the companies` emissions, but do not normally make any requirements concerning their production processes. An energy agreement, on the other hand, focuses on uncovering actual possibilities for energy savings through energy inspections and requirements concerning an energy management system at the companies. About 7,000 companies have environmental approval and about 200 have entered into an energy agreement. Case studies based on qualitative interviews with the companies` managements, the regulatory authorities` case officers and the energy consultants. Case studies were carried out of energy agreements and environmental approvals at four companies selected to span the spectrum from small enterprises with a relatively simple pollution profile (two potato starch factories) to large companies with a complicated pollution profile (two foundries). The case studies gave a close understanding of the regulatory processes and insight into the relationships between them. On the other hand, they did not provide much basis for generalisation. The case studies show that there is an interaction between the different environmental aspects of the companies` production

  8. French approval procedures for pyrotechnical automotive safety equipments

    OpenAIRE

    Aufauvre, Lionel; Branka, Ruddy

    2005-01-01

    International audience; Pyrotechnical articles for civil uses may be subject to national procedures before placing on the market According to the French decree n°90-153, 16 February 1990 as modified; explosives that are dispensed with EC marking and that are not excluded of the decree application have to conform to approved types. Pyrotechnical automotive safety equipments such gas generators for airbag modules or seat-belt pretensioners, pyrotechnie relay compositions and/or igniters inside ...

  9. Approved but non-funded vaccines: accessing individual protection.

    Science.gov (United States)

    Scheifele, David W; Ward, Brian J; Halperin, Scott A; McNeil, Shelly A; Crowcroft, Natasha S; Bjornson, Gordean

    2014-02-07

    Funded immunization programs are best able to achieve high participation rates, optimal protection of the target population, and indirect protection of others. However, in many countries public funding of approved vaccines can be substantially delayed, limited to a portion of the at-risk population or denied altogether. In these situations, unfunded vaccines are often inaccessible to individuals at risk, allowing potentially avoidable morbidity and mortality to continue to occur. We contend that private access to approved but unfunded vaccines should be reconsidered and encouraged, with recognition that individuals have a prerogative to take advantage of a vaccine of potential benefit to them whether it is publicly funded or not. Moreover, numbers of "approved but unfunded" vaccines are likely to grow because governments will not be able to fund all future vaccines of potential benefit to some citizens. New strategies are needed to better use unfunded vaccines even though the net benefits will fall short of those of funded programs. Canada, after recent delays funding several new vaccine programs, has developed means to encourage private vaccine use. Physicians are required to inform relevant patients about risks and benefits of all recommended vaccines, publicly funded or not. Likewise, some provincial public health departments now recommend and promote both funded and unfunded vaccines. Pharmacists are key players in making unfunded vaccines locally available. Professional organizations are contributing to public and provider education about unfunded vaccines (e.g. herpes zoster, not funded in any province). Vaccine companies are gaining expertise with direct-to-consumer advertising. However, major challenges remain, such as making unfunded vaccines more available to low-income families and overcoming public expectations that all vaccines will be provided cost-free, when many other recommended personal preventive measures are user-pay. The greatest need is to

  10. Chinese Government Approves Nanhai Oil Refinery Project of CNOOC

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ The Nanhai Oil Refinery Project independently funded by CNOOC was approved by the related governmental departments in late July. The offshore oil giant builds the 12 million ton-per-year oil refinery in Guangdong Province in the next three years to tap the lucrative South China oil market.The investment in the project will total at least 16 billion yuan (US$1.93 billion).

  11. Lessons from innovation in drug-device combination products.

    Science.gov (United States)

    Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

    2012-01-01

    Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon.

  12. 25 CFR 224.71 - What standards will the Secretary use to decide to approve a final proposed TERA?

    Science.gov (United States)

    2010-04-01

    ... approve a final proposed TERA? 224.71 Section 224.71 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE... the Secretary use to decide to approve a final proposed TERA? The Secretary will consider the best... approve a final proposed TERA. The Secretary must approve a final proposed TERA if it contains...

  13. 42 CFR 84.35 - Changes or modifications of approved respirators; issuance of modification of certificate of...

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Changes or modifications of approved respirators... modifications of approved respirators; issuance of modification of certificate of approval. (a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of...

  14. Production Potential of 47Sc Using Spallation Neutron Flux at the Los Alamos Isotope Production Facility

    Science.gov (United States)

    2014-03-27

    Ohio DISTRIBUTION STATEMENT A APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED The views expressed in this document are those of the author and do...targets at the Los Alamos National Laboratory ( LANL ) Isotope Production Facility (IPF). Targets were activated for 1 hr using an average proton beam...for 47SC production is the unique neutron flux that results from this unique beam/target structure [8]. 1.3 Summary The remainder of this document is

  15. 75 FR 67054 - Listing of Approved Drug Products Containing Dronabinol in Schedule III

    Science.gov (United States)

    2010-11-01

    ..., irritability, mild agitation, anxiety, anger, insomnia, sleep EEG disturbances, nausea, decreased appetite, and... issues concerning which the person desires to be heard and the requestor's interest in the proceeding... factual evidence and expert opinion regarding the issues involved in the issuance, amendment or repeal...

  16. Production of Basal Bodies in bulk for dense multicilia formation [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Xiumin Yan

    2016-06-01

    Full Text Available Centriole number is normally under tight control and is directly linked to ciliogenesis. In cells that use centrosomes as mitotic spindle poles, one pre-existing mother centriole is allowed to duplicate only one daughter centriole per cell cycle. In multiciliated cells, however, many centrioles are generated to serve as basal bodies of the cilia. Although deuterosomes were observed more than 40 years ago using electron microscopy and are believed to produce most of the basal bodies in a mother centriole-independent manner, the underlying molecular mechanisms have remained unknown until recently. From these findings arise more questions and a call for clarifications that will require multidisciplinary efforts.

  17. Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

    OpenAIRE

    Nair, Anil K.; Anand, Om; Chun, Nam; Conner, Dale P.; Mehta, Mehul U.; Nhu, Duong T.; Polli, James E.; Yu, Lawrence X.; Davit, Barbara M.

    2012-01-01

    The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were cl...

  18. 78 FR 67985 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

    Science.gov (United States)

    2013-11-13

    ... therapy. As a drug is used more widely or under diverse conditions, new information regarding the risks... applicant should submit a proposed narrative description of the proposed labeling change in the CBE-0 supplement for posting on the FDA Web page. This brief narrative description should include the...

  19. 78 FR 58273 - Approval for Manufacturing (Production) Authority, Foreign-Trade Zone 284, Liberty Pumps, Inc...

    Science.gov (United States)

    2013-09-23

    ..., Liberty Pumps, Inc. (Submersible and Water Pumps), Bergen, New York Pursuant to its authority under the... Pumps, Inc., within FTZ 284 in Bergen, New York (FTZ Docket 5-2012, filed 1-12-2012); Whereas, notice... procedures within FTZ 284 on behalf of Liberty Pumps, Inc., as described in the application and...

  20. 7 CFR 58.149 - Alternate quality control programs for dairy products.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Alternate quality control programs for dairy products... FOR GRADES OF DAIRY PRODUCTS 1 General Specifications for Dairy Plants Approved for USDA Inspection... for dairy products. (a) When a plant has in operation an acceptable quality control program which...

  1. 25 CFR 163.19 - Contracts for the sale of forest products.

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Contracts for the sale of forest products. 163.19 Section... REGULATIONS Forest Management and Operations § 163.19 Contracts for the sale of forest products. (a) In sales of forest products with an appraised stumpage value exceeding $15,000, the contract forms approved...

  2. 78 FR 38053 - Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug...

    Science.gov (United States)

    2013-06-25

    ... Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safety or... products approved under new drug application (NDA) 21-610 were not withdrawn from sale for reasons of... of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow...

  3. 17 CFR 39.4 - Procedures for implementing derivatives clearing organization rules and clearing new products.

    Science.gov (United States)

    2010-04-01

    ... derivatives clearing organization rules and clearing new products. 39.4 Section 39.4 Commodity and Securities... implementing derivatives clearing organization rules and clearing new products. (a) Request for approval of... of § 40.6 of this chapter. (c) Acceptance of new products for clearing. (1) A dormant...

  4. Streamlining of building permit approval processing of town and country planning department in Ghana

    Directory of Open Access Journals (Sweden)

    Noriss Kweku Hammah

    2015-12-01

    Full Text Available To date, the Ghanaian development control system has proven unsuccessful in delivering quality planning application approvals in a timely manner and it is doubtful whether it is possible to achieve that basic goal in its current form. Planning application approval assessment is performed conjointly by various planning organizations spearheaded by Accra Town and Country Planning Department (TCPD. The success in delivering quality approvals in a timely manner therefore depends on the inter-organizational task interdependency, collaboration, and teamwork of the various planning agencies that form the Accra Metropolitan Assembly. The paper puts into perspective the TCPD organizational workflow and knowledge flow based on their strategies, size, leadership style, organizational complexities, and their competencies to contribute to the success of the approval process. Further, this paper examines the reasons behind the increasing amorphous planning and unapproved development/construction and identifies the various planning approval problems. Finally, it offers modalities to curtail planning approval delays.

  5. Statistical assessment of biosimilar products.

    Science.gov (United States)

    Chow, Shein-Chung; Liu, Jen-Pei

    2010-01-01

    Biological products or medicines are therapeutic agents that are produced using a living system or organism. Access to these life-saving biological products is limited because of their expensive costs. Patents on the early biological products will soon expire in the next few years. This allows other biopharmaceutical/biotech companies to manufacture the generic versions of the biological products, which are referred to as follow-on biological products by the U.S. Food and Drug Administration (FDA) or as biosimilar medicinal products by the European Medicine Agency (EMEA) of the European Union (EU). Competition of cost-effective follow-on biological products with equivalent efficacy and safety can cut down the costs and hence increase patients' access to the much-needed biological pharmaceuticals. Unlike for the conventional pharmaceuticals of small molecules, the complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make evaluation of equivalence (similarity) between the biosimilar products and their corresponding innovator product a great challenge for both the scientific community and regulatory agencies. In this paper, we provide an overview of the current regulatory requirements for approval of biosimilar products. A review of current criteria for evaluation of bioequivalence for the traditional chemical generic products is provided. A detailed description of the differences between the biosimilar and chemical generic products is given with respect to size and structure, immunogenicity, product quality attributed, and manufacturing processes. In addition, statistical considerations including design criteria, fundamental biosimilar assumptions, and statistical methods are proposed. The possibility of using genomic data in evaluation of biosimilar products is also explored.

  6. Translating Social Motivation into Action: Contributions of Need for Approval to Children’s Social Engagement

    OpenAIRE

    RUDOLPH, KAREN D.; Bohn, Lauren E.

    2013-01-01

    This research examined how children’s need for approval (NFA) from peers predicted social behavior (prosocial behavior, aggression, social helplessness) and peer responses (acceptance, victimization, exclusion). Children (N = 526, M age = 7.95, SD = .33) reported on need for approval and teachers reported on social engagement. Approach NFA (motivation to gain approval) predicted more positive engagement and less conflictual engagement and disengagement. Conversely, avoidance NFA (motivation t...

  7. [Approval of ISO/IEC 17025 and quality control of laboratory testing].

    Science.gov (United States)

    Yamamoto, Shigeki; Asakura, Hiroshi; Machii, Kenji; Igimi, Shizunobu

    2010-01-01

    First section of Division of Biomedical Food Research, National Institute of Health Sciences (NIHS) was approved by ISO/IEC 17025 as a laboratory having an appropriate laboratory testing technique. NIHS is the first national laboratory approved by ISO/IEC 17025. NIHS has also been accepted the appropriate technique and facility for the BSL3 level pathogens by ISO/IEC 17025. NIHS is necessary to take an external audit almost every year. This approval is renewed every 4 years.

  8. Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils

    Science.gov (United States)

    2009-02-18

    qualification plan entitled "Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and Oils," produced by the subcontractor, Southwest...102 Enclosure 1 February 12, 2009 Fuel Qualification Plan; 3/27/07–4/24/09 Commercial Approval Plan for Synthetic Jet Fuel from Hydrotreated Fats and...Institute, Grand Forks, ND Southwest Research Institute, San Antonio, TX CLIN 0008 10 COMMERCIAL APPROVAL PLAN FOR SYNTHETIC JET FUEL FROM HYDROTREATED FATS

  9. A Needs Assessment of Marriage and Family Therapy Approved Supervision in Utah

    OpenAIRE

    2005-01-01

    This research presents data gathered through a needs assessment regarding approved supervision in Utah. A sample of ISO therapists in Utah gave descriptive facts about the current need for supervision in Utah as well as the number of therapists that are willing to provide supervision. Additionally, therapists that are not currently approved supervisors indicated whether or not they would be willing to become approved supervisors, what would make the designation more appealing, and what would ...

  10. 21 CFR 310.541 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Science.gov (United States)

    2010-04-01

    ... and part 314 of this chapter is required for marketing. In the absence of an approved application..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  11. 21 CFR 310.536 - Drug products containing active ingredients offered over-the-counter (OTC) for use as a...

    Science.gov (United States)

    2010-04-01

    ... 505 of the act and part 314 of this chapter is required for marketing. In the absence of an approved... product initially introduced or initially delivered for introduction into interstate commerce that is...

  12. 21 CFR 310.542 - Over-the-counter (OTC) drug products containing active ingredients offered for use in the...

    Science.gov (United States)

    2010-04-01

    ... and part 314 of this chapter is required for marketing. In the absence of an approved application..., 1990, any such OTC drug product initially introduced or initially delivered for introduction...

  13. 21 CFR 310.546 - Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and...

    Science.gov (United States)

    2010-04-01

    ... the act and part 314 of this chapter is required for marketing. In the absence of an approved new drug..., any such OTC drug product initially introduced or initially delivered for introduction into...

  14. 21 CFR 310.537 - Drug products containing active ingredients offered over-the-counter (OTC) for oral...

    Science.gov (United States)

    2010-04-01

    ... is required for marketing. In the absence of an approved application, such product is also misbranded... or initially delivered for introduction into interstate commerce that is not in compliance with...

  15. Recently approved systemic therapies for acne vulgaris and rosacea.

    Science.gov (United States)

    Del Rosso, James Q

    2007-08-01

    Until recently, with the exception of oral isotretinoin for the treatment of severe recalcitrant nodular acne, systemic therapy for acne vulgaris and rosacea has been based on anecdotal support, clinical experience, and small clinical trials. Tetracycline derivatives are the predominant systemic agents that have been used for both disease states, prescribed in dose ranges that produce antibiotic activity. Anti-inflammatory dose doxycycline, a controlled-release (CR) 40-mg capsule formulation of doxycycline that is devoid of antibiotic activity when administered once daily, was US Food and Drug Administration (FDA)-approved for the treatment of inflammatory lesions (papules and pustules) of rosacea, based on large-scale phase 3 pivotal trials and long-term microbiologic and safety data. Also, an extended-release (ER) tablet formulation of minocycline was approved by the FDA for the treatment of inflammatory lesions of moderate to severe acne vulgaris in patients 12 years and older based on large-scale phase 3 clinical trials that evaluated efficacy and safety, dose-response analysis, and long-term data. This article discusses the studies and clinical applications related to the use of these agents.

  16. Japanese government takes steps toward approving birth control pill.

    Science.gov (United States)

    1995-10-27

    On September 12, 1995, the Central Pharmaceutical Affairs Council of Japan recommended approval of low-dose oral contraceptives as a method of family planning. Doctors should be able to prescribe the pills after the standing members of the Council, part of the Ministry of Health and Family Welfare, meet next March. High-dose oral contraceptives can be obtained currently to treat menstrual irregularities, although many of the 200,000 prescriptions written annually are used for family planning. Approval for the low-dose contraceptives has been slow because of concerns regarding a possible relaxation of sexual mores (1965); adverse side effects (until 1987 when the Japanese Ministry of Health initiated clinical trials that established the safety and efficacy of the contraceptives); increased rates of human immunodeficiency virus (HIV) infection (1992); a higher number of drug reimbursement claims under the national health insurance system; and a decline in Japan's birthrate. Japan's birthrate fell from 4.5 children per woman in 1947 to 1.5 in 1993. 80% of contraceptive users rely on condom; 22% use the rhythm method, usually in conjunction with the condom; 7% use the IUD; and less than 2% use sterilization. Sterilization is only permitted for married couples and only when the woman's life or health is in danger, or either spouse has a mental illness, leprosy, or a hereditary disorder.

  17. 21 CFR 601.12 - Changes to an approved application.

    Science.gov (United States)

    2010-04-01

    ... the product as they may relate to the safety or effectiveness of the product. (3) Notwithstanding the... labeling and advertising to make it consistent with any labeling change implemented in accordance with... product as they may relate to the safety or effectiveness of the product. (2) These changes include,...

  18. Announcement of Newly Approved National Standards of P. R. China 2006 No.13 (total No. 100)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 371 national standards and publicize now.

  19. Announcement of Newly Approved National Standards of P. R. China 2006 No.11 (total No.98)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 220 national standards and publicize now.

  20. Announcement of Newly Approved National Standards of P. R. China 2007 No.4 (total No. 104)

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ General Administration of Quality Supervision, Inspection and Quarantine of P.R. China and Standardization Administration of China have approved the following 114 national standards and publicize now.