WorldWideScience

Sample records for anti-infective drugs advisory

  1. 77 FR 12063 - Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs...

    Science.gov (United States)

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  2. Antimycobacterial drug discovery using Mycobacteria-infected amoebae identifies anti-infectives and new molecular targets.

    Science.gov (United States)

    Trofimov, Valentin; Kicka, Sébastien; Mucaria, Sabrina; Hanna, Nabil; Ramon-Olayo, Fernando; Del Peral, Laura Vela-Gonzalez; Lelièvre, Joël; Ballell, Lluís; Scapozza, Leonardo; Besra, Gurdyal S; Cox, Jonathan A G; Soldati, Thierry

    2018-03-02

    Tuberculosis remains a serious threat to human health world-wide, and improved efficiency of medical treatment requires a better understanding of the pathogenesis and the discovery of new drugs. In the present study, we performed a whole-cell based screen in order to complete the characterization of 168 compounds from the GlaxoSmithKline TB-set. We have established and utilized novel previously unexplored host-model systems to characterize the GSK compounds, i.e. the amoeboid organisms D. discoideum and A. castellanii, as well as a microglial phagocytic cell line, BV2. We infected these host cells with Mycobacterium marinum to monitor and characterize the anti-infective activity of the compounds with quantitative fluorescence measurements and high-content microscopy. In summary, 88.1% of the compounds were confirmed as antibiotics against M. marinum, 11.3% and 4.8% displayed strong anti-infective activity in, respectively, the mammalian and protozoan infection models. Additionally, in the two systems, 13-14% of the compounds displayed pro-infective activity. Our studies underline the relevance of using evolutionarily distant pathogen and host models in order to reveal conserved mechanisms of virulence and defence, respectively, which are potential "universal" targets for intervention. Subsequent mechanism of action studies based on generation of over-expresser M. bovis BCG strains, generation of spontaneous resistant mutants and whole genome sequencing revealed four new molecular targets, including FbpA, MurC, MmpL3 and GlpK.

  3. An update on the use of C. elegans for preclinical drug discovery: screening and identifying anti-infective drugs.

    Science.gov (United States)

    Kim, Wooseong; Hendricks, Gabriel Lambert; Lee, Kiho; Mylonakis, Eleftherios

    2017-06-01

    The emergence of antibiotic-resistant and -tolerant bacteria is a major threat to human health. Although efforts for drug discovery are ongoing, conventional bacteria-centered screening strategies have thus far failed to yield new classes of effective antibiotics. Therefore, new paradigms for discovering novel antibiotics are of critical importance. Caenorhabditis elegans, a model organism used for in vivo, offers a promising solution for identification of anti-infective compounds. Areas covered: This review examines the advantages of C. elegans-based high-throughput screening over conventional, bacteria-centered in vitro screens. It discusses major anti-infective compounds identified from large-scale C. elegans-based screens and presents the first clinically-approved drugs, then known bioactive compounds, and finally novel small molecules. Expert opinion: There are clear advantages of using a C. elegans-infection based screening method. A C. elegans-based screen produces an enriched pool of non-toxic, efficacious, potential anti-infectives, covering: conventional antimicrobial agents, immunomodulators, and anti-virulence agents. Although C. elegans-based screens do not denote the mode of action of hit compounds, this can be elucidated in secondary studies by comparing the results to target-based screens, or conducting subsequent target-based screens, including the genetic knock-down of host or bacterial genes.

  4. Advisory Board on Alcoholism and Drug Abuse

    Science.gov (United States)

    State Employees Advisory Board on Alcoholism and Drug Abuse DHSS State of Alaska Home Divisions and ; Advisory Board on Alcoholism and Drug Abuse Page Content Alison Kulas Executive Director If you, a family Kulas Begins Tenure as Executive Director The Advisory Board on Alcoholism and Drug Abuse, The Alaska

  5. A Review of Antimicrobial Peptides and Their Therapeutic Potential as Anti-Infective Drugs

    Science.gov (United States)

    Gordon, Y. Jerold; Romanowski, Eric G.; McDermott, Alison M.

    2006-01-01

    Purpose. Antimicrobial peptides (AMPs) are an essential part of innate immunity that evolved in most living organisms over 2.6 billion years to combat microbial challenge. These small cationic peptides are multifunctional as effectors of innate immunity on skin and mucosal surfaces and have demonstrated direct antimicrobial activity against various bacteria, viruses, fungi, and parasites. This review summarizes their progress to date as commercial antimicrobial drugs for topical and systemic indications. Methods. Literature review. Results. Despite numerous clinical trials, no modified AMP has obtained Food & Drug Administration approval yet for any topical or systemic medical indications. Conclusions. While AMPs are recognized as essential components of natural host innate immunity against microbial challenge, their usefulness as a new class of antimicrobial drugs still remains to be proven. PMID:16020284

  6. Drug loaded homogeneous electrospun PCL/gelatin hybrid nanofiber structures for anti-infective tissue regeneration membranes.

    Science.gov (United States)

    Xue, Jiajia; He, Min; Liu, Hao; Niu, Yuzhao; Crawford, Aileen; Coates, Phil D; Chen, Dafu; Shi, Rui; Zhang, Liqun

    2014-11-01

    Infection is the major reason for guided tissue regeneration/guided bone regeneration (GTR/GBR) membrane failure in clinical application. In this work, we developed GTR/GBR membranes with localized drug delivery function to prevent infection by electrospinning of poly(ε-caprolactone) (PCL) and gelatin blended with metronidazole (MNA). Acetic acid (HAc) was introduced to improve the miscibility of PCL and gelatin to fabricate homogeneous hybrid nanofiber membranes. The effects of the addition of HAc and the MNA content (0, 1, 5, 10, 20, 30, and 40 wt.% of polymer) on the properties of the membranes were investigated. The membranes showed good mechanical properties, appropriate biodegradation rate and barrier function. The controlled and sustained release of MNA from the membranes significantly prevented the colonization of anaerobic bacteria. Cells could adhere to and proliferate on the membranes without cytotoxicity until the MNA content reached 30%. Subcutaneous implantation in rabbits for 8 months demonstrated that MNA-loaded membranes evoked a less severe inflammatory response depending on the dose of MNA than bare membranes. The biodegradation time of the membranes was appropriate for tissue regeneration. These results indicated the potential for using MNA-loaded PCL/gelatin electrospun membranes as anti-infective GTR/GBR membranes to optimize clinical application of GTR/GBR strategies. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Macrolide Hybrid Compounds: Drug Discovery Opportunities in Anti- Infective and Anti-inflammatory Area.

    Science.gov (United States)

    Paljetak, Hana Cipcic; Tomaskovic, Linda; Matijasic, Mario; Bukvic, Mirjana; Fajdetic, Andrea; Verbanac, Donatella; Peric, Mihaela

    2017-01-01

    Macrolides, polyketide natural products, and their 15-membered semi-synthetic derivatives are composed of substituted macrocyclic lactone ring and used primarily as potent antibiotics. Recently their usefulness was extended to antimalarial and anti-inflammatory area. Hybrid macrolides presented in this article are the next generation semi-synthetic compounds that combine pharmacophores from antibacterial, antimalarial and anti-inflammatory area with 14- and 15-membered azalide scaffolds. Antibacterial azalide hybrids with sulphonamides showed improved activity against resistant streptococci while quinolone conjugates demonstrated full coverage of respiratory pathogens including macrolide resistant strains and their efficacy was confirmed in mouse pneumonia model. Antimalarial macrolide hybrids, mainly involving (chloro)quinoline pharmacophores, showed outstanding activity against chloroquine resistant strains, favourable pharmacokinetics, promising in vivo efficacy as well as encouraging developmental potential. Anti-inflammatory hybrids were obtained by combining macrolides with corticosteroid and non-steroidal anti-inflammatory drugs. They were found active in in vivo animal models of locally induced inflammation, asthma, inflammatory bowel disease and rheumatoid arthritis and demonstrated improved safety over parent steroid drugs. Overall, macrolide hybrids possess significant potential to be developed as potent novel medicines in therapeutic areas of utmost pharmaceutical interest. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. 77 FR 69869 - National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug...

    Science.gov (United States)

    2012-11-21

    ... Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board... Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National...: National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and...

  9. 77 FR 13612 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... plague (plague infection with extensive lung involvement) in African Green Monkeys and provide advice.... Safety and other supportive information is derived from clinical studies and post-marketing experience in... studies and post-marketing experience in humans. FDA intends to make background material available to the...

  10. 76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

    Science.gov (United States)

    2011-07-29

    .... FDA-2010-N-0002] Advisory Committee; Medical Imaging Drugs Advisory Committee; Re- Establishment... (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging...

  11. Improving pharmacokinetic-pharmacodynamic modeling to investigate anti-infective chemotherapy with application to the current generation of antimalarial drugs.

    Directory of Open Access Journals (Sweden)

    Katherine Kay

    Full Text Available Mechanism-based pharmacokinetic-pharmacodynamic (PK/PD modelling is the standard computational technique for simulating drug treatment of infectious diseases with the potential to enhance our understanding of drug treatment outcomes, drug deployment strategies, and dosing regimens. Standard methodologies assume only a single drug is used, it acts only in its unconverted form, and that oral drugs are instantaneously absorbed across the gut wall to their site of action. For drugs with short half-lives, this absorption period accounts for a significant period of their time in the body. Treatment of infectious diseases often uses combination therapies, so we refined and substantially extended the PK/PD methodologies to incorporate (i time lags and drug concentration profiles resulting from absorption across the gut wall and, if required, conversion to another active form; (ii multiple drugs within a treatment combination; (iii differing modes of action of drugs in the combination: additive, synergistic, antagonistic; (iv drugs converted to an active metabolite with a similar mode of action. This methodology was applied to a case study of two first-line malaria treatments based on artemisinin combination therapies (ACTs, artemether-lumefantrine and artesunate-mefloquine where the likelihood of increased artemisinin tolerance/resistance has led to speculation on their continued long-term effectiveness. We note previous estimates of artemisinin kill rate were underestimated by a factor of seven, both the unconverted and converted form of the artemisinins kill parasites and the extended PK/PD methodology produced results consistent with field observations. The simulations predict that a potentially rapid decline in ACT effectiveness is likely to occur as artemisinin resistance spreads, emphasising the importance of containing the spread of artemisinin resistance before it results in widespread drug failure. We found that PK/PD data is generally very

  12. 78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

    Science.gov (United States)

    2013-02-25

    ...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...

  13. 78 FR 57166 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-09-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  14. 77 FR 31025 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  15. 77 FR 58399 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  16. 78 FR 13348 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  17. 77 FR 32125 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  18. 75 FR 9419 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  19. 78 FR 48690 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  20. 77 FR 5813 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  1. 77 FR 50702 - Cardiovascular and Renal Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for...

  2. 76 FR 82309 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  3. 76 FR 11489 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  4. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  5. 77 FR 25184 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  6. 76 FR 44595 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  7. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  8. 76 FR 82310 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  9. 76 FR 65736 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  10. 75 FR 75680 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug...

  11. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-12-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is...

  12. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-10-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is...

  13. 78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-04-04

    ... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...

  14. 76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143

  15. 77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...

  16. 75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-11-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...

  17. 75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

    Science.gov (United States)

    2010-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...

  18. Transparency in Canadian public drug advisory committees.

    Science.gov (United States)

    Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M

    2014-11-01

    Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

  20. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-24

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

  1. 78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-23

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

  2. 78 FR 17413 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-21

    ...] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... rescheduled due to the postponement of the March 7, 2013, Pulmonary-Allergy Drugs Advisory Committee meeting due to unanticipated weather conditions. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee...

  3. 75 FR 8377 - Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-02-24

    ...] Pulmonary-Allergy Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... of a meeting of the Pulmonary-Allergy Drugs Advisory Committee. This meeting was announced in the... February 2, 2010, FDA announced that a meeting of the Pulmonary-Allergy Drugs Advisory Committee would be...

  4. 76 FR 61713 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-05

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... adult oncology indication, or in late stage development in pediatric patients with cancer. The...

  5. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-04-06

    ...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

  6. 76 FR 36930 - National Advisory Council on Alcohol Abuse and Alcoholism and National Advisory Council on Drug...

    Science.gov (United States)

    2011-06-23

    ... Alcohol Abuse and Alcoholism and National Advisory Council on Drug Abuse; Notice of Joint Meeting Pursuant... given of a joint meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The meeting will be open to the public as indicated below, with...

  7. 78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-03-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...

  8. 76 FR 40735 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-07-11

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...

  9. 78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2013-01-14

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...

  10. 76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

    Science.gov (United States)

    2011-09-23

    ...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...

  11. 77 FR 12062 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee...

  12. 77 FR 43093 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  13. 78 FR 38717 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  14. 75 FR 35496 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  15. 77 FR 43600 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  16. 75 FR 1395 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0664] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  17. 78 FR 36787 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  18. 75 FR 52762 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  19. 75 FR 30839 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  20. 76 FR 82310 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  1. 76 FR 39404 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  2. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-05-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  3. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-19

    ...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

  4. 75 FR 12768 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  5. 76 FR 44595 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee...

  6. 78 FR 20328 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  7. 78 FR 63478 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  8. 75 FR 36428 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  9. 77 FR 20037 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  10. 76 FR 3912 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  11. 75 FR 17417 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  12. 78 FR 63481 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...

  13. 78 FR 734 - Medical Imaging Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-04

    ...] Medical Imaging Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  14. 75 FR 9420 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  15. 76 FR 29766 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  16. 77 FR 4566 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  17. 77 FR 69635 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  18. 75 FR 5334 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  19. 75 FR 82031 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  20. 77 FR 74486 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  1. 77 FR 69636 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  2. 75 FR 5333 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  3. 78 FR 46976 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  4. 76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-24

    ... committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed...] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration...: Dermatologic and Ophthalmic Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  5. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and..., Inc., for the proposed indication to reduce the risk of thrombotic cardiovascular events in patients...

  6. 78 FR 76307 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. FDA intends...

  7. 75 FR 57474 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-21

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... analyses of the TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) study of ARANESP...

  8. 75 FR 70933 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-11-19

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committees... appropriate clinical study design for thromboxane receptor antagonists for prevention of cardiovascular events...

  9. 77 FR 21982 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-12

    ...] Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and...., to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS...

  10. 75 FR 75681 - Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-06

    ...] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide...) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The...

  11. 76 FR 58520 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General...

  12. 75 FR 66773 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-29

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... or, are in late stage development for an adult oncology indication. The subcommittee will consider...

  13. 77 FR 57095 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-17

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... that are in development for an adult oncology indication. The subcommittee will consider and discuss...

  14. 78 FR 63222 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... the public. Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory... measures in the pediatric development plans of oncology products. The half-day session will provide an...

  15. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ...] Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. General... oncology indications. The subcommittee will consider and discuss issues relating to the development of each...

  16. 76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2011-11-14

    ...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... be limited. If the number of registrants requesting to speak is greater than can be reasonably...

  17. 78 FR 734 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2013-01-04

    ...] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Committee for Reproductive Health Drugs. General Function of the Committee: To provide advice and... limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated...

  18. Genotoxicity of topoisomerase II inhibitors: An anti-infective perspective

    International Nuclear Information System (INIS)

    Smart, Daniel J.

    2008-01-01

    At present, an inevitable consequence of a chemical's inhibitory activity on key regulators of DNA topology in bacteria, the type II topoisomerases, is a less pronounced effect on their eukaryotic counterparts. In the context of anti-infectives drug development, this may pose a risk to patient safety as inhibition of eukaryotic type II topoisomerases (TOPO II) can result in the generation of DNA double-strand breaks (DSBs), which have the potential to manifest as mutations, chromosome breakage or cell death. The biological effects of several TOPO II inhibitors in mammalian cells are described herein; their modulation of DSB damage response parameters is examined and evidence for the existence of a threshold concept for genotoxicity and its relevance in safety assessment is discussed. The potential utility of γH2AX, a promising and highly sensitive molecular marker for DSBs, in a novel genotoxicity 'pre-screen' to conventional assays is also highlighted

  19. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Science.gov (United States)

    2010-04-22

    ...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

  20. 75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-06-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

  1. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Science.gov (United States)

    2011-10-14

    ...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...

  2. 78 FR 76308 - Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-17

    ...: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and... enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research... system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic...

  3. 77 FR 50701 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-08-22

    ... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome. FDA intends to make background material available to the...

  4. 76 FR 59404 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-26

    ..., efficacy, and durability of response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea. FDA intends to make background material...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee link. Procedure...

  5. 76 FR 12972 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory...

    Science.gov (United States)

    2011-03-09

    ....gov . Submit written comments to the Division of Dockets Management, Food and Drug Administration... be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday... telephone number is 301- 589-5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research...

  6. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

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

  7. 77 FR 17487 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-26

    ... line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss new drug application (NDA) 203- 100, for a fixed-dose combination tablet of...

  8. 75 FR 65362 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-22

    ... Hampshire Ave., Silver Spring, MD 20993-0002. Information regarding special accommodations due to a... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver...) Soft Gelatin Capsules, [[Page 65363

  9. Marine Peptides and Their Anti-Infective Activities

    OpenAIRE

    Kang, Hee Kyoung; Seo, Chang Ho; Park, Yoonkyung

    2015-01-01

    Marine bioresources are a valuable source of bioactive compounds with industrial and nutraceutical potential. Numerous clinical trials evaluating novel chemotherapeutic agents derived from marine sources have revealed novel mechanisms of action. Recently, marine-derived bioactive peptides have attracted attention owing to their numerous beneficial effects. Moreover, several studies have reported that marine peptides exhibit various anti-infective activities, such as antimicrobial, antifungal,...

  10. Anti-infection treatment of iatrogenic acute radiation sickness

    International Nuclear Information System (INIS)

    Zhang Shulan; Ke Xiaoyan; Jia Tengzhen

    2006-01-01

    Objective: To occumulatle experience of anti-infection treatment in acute radiation sickness (ARS) induced by medical treatment in order to provide beneficial help for victims of accidental of acute radiation sickness. Methods: The changes of peripheral blood indices, body temperature and clinical symptoms of 17 cases who were clinically irradiated with 6.0-7.2 Gy X-rays were observed both before peripheral blood stem cell transplantation(PBSCT) and after anti-infection treatment. Results: WBC count began to decrease to below 1 x 10 9 /L from the 8th to 10th days after irradiation and maintained at row level for 4 days or for 13.3 days if the patients had not received rhG-CSF treatment. In 29.4% of patients the body temperature was higher than 38.5 degree C. After comprehensive enviromental protection and anti-infection treatment, all patients could successfully tide over the period of bone marrow depression without appearance of the typical critical phase of ARS. Conclusion: PBSCT and rhG-CSF treatment can reduce the time span for reconstruction of bone marrow. Comprehensive enviromental protection and combined anti-infection treatment are key points fm successful treatment. (authors)

  11. Antimicrobial peptides: Possible anti-infective agents.

    Science.gov (United States)

    Lakshmaiah Narayana, Jayaram; Chen, Jyh-Yih

    2015-10-01

    Multidrug-resistant bacterial, fungal, viral, and parasitic infections are major health threats. The Infectious Diseases Society of America has expressed concern on the decrease of pharmaceutical companies working on antibiotic research and development. However, small companies, along with academic research institutes, are stepping forward to develop novel therapeutic methods to overcome the present healthcare situation. Among the leading alternatives to current drugs are antimicrobial peptides (AMPs), which are abundantly distributed in nature. AMPs exhibit broad-spectrum activity against a wide variety of bacteria, fungi, viruses, and parasites, and even cancerous cells. They also show potential immunomodulatory properties, and are highly responsive to infectious agents and innate immuno-stimulatory molecules. In recent years, many AMPs have undergone or are undergoing clinical development, and a few are commercially available for topical and other applications. In this review, we outline selected anion and cationic AMPs which are at various stages of development, from preliminary analysis to clinical drug development. Moreover, we also consider current production methods and delivery tools for AMPs, which must be improved for the effective use of these agents. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Limited-sampling strategies for anti-infective agents: systematic review.

    Science.gov (United States)

    Sprague, Denise A; Ensom, Mary H H

    2009-09-01

    Area under the concentration-time curve (AUC) is a pharmacokinetic parameter that represents overall exposure to a drug. For selected anti-infective agents, pharmacokinetic-pharmacodynamic parameters, such as AUC/MIC (where MIC is the minimal inhibitory concentration), have been correlated with outcome in a few studies. A limited-sampling strategy may be used to estimate pharmacokinetic parameters such as AUC, without the frequent, costly, and inconvenient blood sampling that would be required to directly calculate the AUC. To discuss, by means of a systematic review, the strengths, limitations, and clinical implications of published studies involving a limited-sampling strategy for anti-infective agents and to propose improvements in methodology for future studies. The PubMed and EMBASE databases were searched using the terms "anti-infective agents", "limited sampling", "optimal sampling", "sparse sampling", "AUC monitoring", "abbreviated AUC", "abbreviated sampling", and "Bayesian". The reference lists of retrieved articles were searched manually. Included studies were classified according to modified criteria from the US Preventive Services Task Force. Twenty studies met the inclusion criteria. Six of the studies (involving didanosine, zidovudine, nevirapine, ciprofloxacin, efavirenz, and nelfinavir) were classified as providing level I evidence, 4 studies (involving vancomycin, didanosine, lamivudine, and lopinavir-ritonavir) provided level II-1 evidence, 2 studies (involving saquinavir and ceftazidime) provided level II-2 evidence, and 8 studies (involving ciprofloxacin, nelfinavir, vancomycin, ceftazidime, ganciclovir, pyrazinamide, meropenem, and alpha interferon) provided level III evidence. All of the studies providing level I evidence used prospectively collected data and proper validation procedures with separate, randomly selected index and validation groups. However, most of the included studies did not provide an adequate description of the methods or

  13. High-throughput screening for novel anti-infectives using a C. elegans pathogenesis model.

    Science.gov (United States)

    Conery, Annie L; Larkins-Ford, Jonah; Ausubel, Frederick M; Kirienko, Natalia V

    2014-03-14

    In recent history, the nematode Caenorhabditis elegans has provided a compelling platform for the discovery of novel antimicrobial drugs. In this protocol, we present an automated, high-throughput C. elegans pathogenesis assay, which can be used to screen for anti-infective compounds that prevent nematodes from dying due to Pseudomonas aeruginosa. New antibiotics identified from such screens would be promising candidates for treatment of human infections, and also can be used as probe compounds to identify novel targets in microbial pathogenesis or host immunity. Copyright © 2014 John Wiley & Sons, Inc.

  14. Marine Peptides and Their Anti-Infective Activities

    Directory of Open Access Journals (Sweden)

    Hee Kyoung Kang

    2015-01-01

    Full Text Available Marine bioresources are a valuable source of bioactive compounds with industrial and nutraceutical potential. Numerous clinical trials evaluating novel chemotherapeutic agents derived from marine sources have revealed novel mechanisms of action. Recently, marine-derived bioactive peptides have attracted attention owing to their numerous beneficial effects. Moreover, several studies have reported that marine peptides exhibit various anti-infective activities, such as antimicrobial, antifungal, antimalarial, antiprotozoal, anti-tuberculosis, and antiviral activities. In the last several decades, studies of marine plants, animals, and microbes have revealed tremendous number of structurally diverse and bioactive secondary metabolites. However, the treatments available for many infectious diseases caused by bacteria, fungi, and viruses are limited. Thus, the identification of novel antimicrobial peptides should be continued, and all possible strategies should be explored. In this review, we will present the structures and anti-infective activity of peptides isolated from marine sources (sponges, algae, bacteria, fungi and fish from 2006 to the present.

  15. Topical anti-infective sinonasal irrigations: update and literature review.

    Science.gov (United States)

    Lee, Jivianne T; Chiu, Alexander G

    2014-01-01

    Sinonasal anti-infective irrigations have emerged as a promising therapeutic modality in the comprehensive management of chronic rhinosinusitis (CRS), particularly in the context of recalcitrant disease. The purpose of this article was to delineate the current spectrum of topical anti-infective therapies available and evaluate their role in the treatment of CRS. A systematic literature review was performed on all studies investigating the use of topical antimicrobial solutions in the medical therapy of CRS. Anti-infective irrigations were stratified into topical antibacterial, antifungal, and additive preparations according to their composition and respective microbicidal properties. The use of topical antibiotic irrigations has been supported by low-level studies in the treatment of refractory CRS, with optimal results achieved in patients who have undergone prior functional endoscopic sinus surgery and received culture-directed therapy. Multiple evidence-based reviews have not established any clinical benefit with the administration of topical antifungals, and their use is not currently recommended in the management of routine CRS. Topical additives including surfactants may be beneficial as adjunctive treatment for recalcitrant CRS, but additional research is needed to investigate their efficacy in comparison with other agents and establish safety profiles. Topical anti-infective solutions are not recommended as first-line therapy for routine CRS but may be considered as a potential option for patients with refractory CRS who have failed traditional medical and surgical intervention. Additional research is necessary to determine which patient populations would derive the most benefit from each respective irrigation regimen and identify potential toxicities associated with prolonged use.

  16. Development of anti-infectives using phage display: biological agents against bacteria, viruses, and parasites.

    Science.gov (United States)

    Huang, Johnny X; Bishop-Hurley, Sharon L; Cooper, Matthew A

    2012-09-01

    The vast majority of anti-infective therapeutics on the market or in development are small molecules; however, there is now a nascent pipeline of biological agents in development. Until recently, phage display technologies were used mainly to produce monoclonal antibodies (MAbs) targeted against cancer or inflammatory disease targets. Patent disputes impeded broad use of these methods and contributed to the dearth of candidates in the clinic during the 1990s. Today, however, phage display is recognized as a powerful tool for selecting novel peptides and antibodies that can bind to a wide range of antigens, ranging from whole cells to proteins and lipid targets. In this review, we highlight research that exploits phage display technology as a means of discovering novel therapeutics against infectious diseases, with a focus on antimicrobial peptides and antibodies in clinical or preclinical development. We discuss the different strategies and methods used to derive, select, and develop anti-infectives from phage display libraries and then highlight case studies of drug candidates in the process of development and commercialization. Advances in screening, manufacturing, and humanization technologies now mean that phage display can make a significant contribution in the fight against clinically important pathogens.

  17. Screening for potential anti-infective agents towards Burkholderia pseudomallei infection

    Science.gov (United States)

    Eng, Su Anne; Nathan, Sheila

    2014-09-01

    The established treatment for melioidosis is antibiotic therapy. However, a constant threat to this form of treatment is resistance development of the causative agent, Burkholderia pseudomallei, towards antibiotics. One option to circumvent this threat of antibiotic resistance is to search for new alternative anti-infectives which target the host innate immune system and/or bacterial virulence. In this study, 29 synthetic compounds were evaluated for their potential to increase the lifespan of an infected host. The nematode Caenorhabditis elegans was adopted as the infection model as its innate immune pathways are homologous to humans. Screens were performed in a liquid-based survival assay containing infected worms exposed to individual compounds and survival of untreated and compound-treated worms were compared. A primary screen identified nine synthetic compounds that extended the lifespan of B. pseudomallei-infected worms. Subsequently, a disc diffusion test was performed on these selected compounds to delineate compounds into those that enhanced the survival of worms via antimicrobial activity i.e. reducing the number of infecting bacteria, or into those that did not target pathogen viability. Out of the nine hits selected, two demonstrated antimicrobial effects on B. pseudomallei. Therefore, the findings from this study suggest that the other seven identified compounds are potential anti-infectives which could protect a host against B. pseudomallei infection without developing the risk of drug resistance.

  18. Bioprospecting Deep-Sea Actinobacteria for Novel Anti-infective Natural Products

    Directory of Open Access Journals (Sweden)

    Dongbo Xu

    2018-04-01

    Full Text Available The global prevalence of drug resistance has created an urgent need for the discovery of novel anti-infective drugs. The major source of antibiotics in current clinical practice is terrestrial actinobacteria; the less-exploited deep-sea actinobacteria may serve as an unprecedented source of novel natural products. In this study, we evaluated 50 actinobacteria strains derived from diverse deep water sponges and environmental niches for their anti-microbial activities against a panel of pathogens including Candida albicans, Clostridium difficile, Staphylococcus aureus, and methicillin-resistant S. aureus (MRSA, and Pseudomonas aeruginosa. More than half of the tested strains (27 were identified as active in at least one assay. The rare earth salt lanthanum chloride (LaCl3 was shown to be as an effective elicitor. Among the 27 strains, the anti-microbial activity of 15 were induced or enhanced by the addition of LaCl3. This part of study focused on one strain R818, in which potent antifungal activity was induced by the addition of LaCl3. We found that the LaCl3-activated metabolites in R818 are likely antimycin-type compounds. One of them, compound 1, has been purified. Spectroscopic analyses including HR-MS and 1D NMR indicated that this compound is urauchimycin D. The antifungal activity of compound 1 was confirmed with a minimal inhibitory concentration (MIC of 25 μg/mL; the purified compound also showed a moderate activity against C. difficile. Additional notable strains are: strain N217 which showed both antifungal and antibacterial (including P. aeruginosa activities and strain M864 which showed potent activity against C. difficile with an MIC value (0.125 μg/mL lower than those of vancomycin and metronidazole. Our preliminary studies show that deep-sea actinobacteria is a promising source of anti-infective natural products.

  19. Innovative Approaches to Improve Anti-Infective Vaccine Efficacy.

    Science.gov (United States)

    Yeaman, Michael R; Hennessey, John P

    2017-01-06

    Safe and efficacious vaccines are arguably the most successful medical interventions of all time. Yet the ongoing discovery of new pathogens, along with emergence of antibiotic-resistant pathogens and a burgeoning population at risk of such infections, imposes unprecedented public health challenges. To meet these challenges, innovative strategies to discover and develop new or improved anti-infective vaccines are necessary. These approaches must intersect the most meaningful insights into protective immunity and advanced technologies with capabilities to deliver immunogens for optimal immune protection. This goal is considered through several recent advances in host-pathogen relationships, conceptual strides in vaccinology, and emerging technologies. Given a clear and growing risk of pandemic disease should the threat of infection go unmet, developing vaccines that optimize protective immunity against high-priority and antibiotic-resistant pathogens represents an urgent and unifying imperative.

  20. The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety

    International Nuclear Information System (INIS)

    Boyd, Ian W.

    2002-01-01

    The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin

  1. 78 FR 63224 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare congenital... Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate...Committees/Calendar/default.htm . Scroll down to the appropriate advisory committee meeting link. Procedure...

  2. 78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-30

    ... treatment of metabolic disorders associated with lipodystrophy, including diabetes mellitus and/or... than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a... 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee...

  3. 75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2010-04-27

    ... of the treatment of hypoactive sexual desire disorder in premenopausal women. FDA intends to make... public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public... least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory...

  4. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Science.gov (United States)

    2010-04-01

    ... and advertising, and regulatory control of the human prescription drugs falling within the... continued approval for marketing; or (3) A particular drug is properly classified as a new drug, an old drug...

  5. Optimization of anti-infective dosing regimens during online haemodiafiltration

    NARCIS (Netherlands)

    Jager, Nynke G. L.; Zandvliet, Anthe S.; Touw, Daniel J.; Penne, Erik L.

    2017-01-01

    Online haemodiafiltration (HDF) is increasingly used in clinical practice as a routine intermittent dialysis modality. It is well known that renal impairment and renal replacement therapy can substantially affect the pharmacokinetic behaviour of several drugs. However, surprisingly few data are

  6. Optimization of anti-infective dosing regimens during online haemodiafiltration

    NARCIS (Netherlands)

    Jager, Nynke G L; Zandvliet, Anthe S; Touw, Daniel J; Penne, Erik L

    Online haemodiafiltration (HDF) is increasingly used in clinical practice as a routine intermittent dialysis modality. It is well known that renal impairment and renal replacement therapy can substantially affect the pharmacokinetic behaviour of several drugs. However, surprisingly few data are

  7. Global occurrence of anti-infectives in contaminated surface waters: Impact of income inequality between countries.

    Science.gov (United States)

    Segura, Pedro A; Takada, Hideshige; Correa, José A; El Saadi, Karim; Koike, Tatsuya; Onwona-Agyeman, Siaw; Ofosu-Anim, John; Sabi, Edward Benjamin; Wasonga, Oliver V; Mghalu, Joseph M; dos Santos Junior, Antonio Manuel; Newman, Brent; Weerts, Steven; Yargeau, Viviane

    2015-07-01

    The presence anti-infectives in environmental waters is of interest because of their potential role in the dissemination of anti-infective resistance in bacteria and other harmful effects on non-target species such as algae and shellfish. Since no information on global trends regarding the contamination caused by these bioactive substances is yet available, we decided to investigate the impact of income inequality between countries on the occurrence of anti-infectives in surface waters. In order to perform such study, we gathered concentration values reported in the peer-reviewed literature between 1998 and 2014 and built a database. To fill the gap of knowledge on occurrence of anti-infectives in African countries, we also collected 61 surface water samples from Ghana, Kenya, Mozambique and South Africa, and measured concentrations of 19 anti-infectives. A mixed one-way analysis of covariance (ANCOVA) model, followed by Turkey-Kramer post hoc tests was used to identify potential differences in anti-infective occurrence between countries grouped by income level (high, upper-middle and lower-middle and low income) according to the classification by the World Bank. Comparison of occurrence of anti-infectives according to income level revealed that concentrations of these substances in contaminated surface waters were significantly higher in low and lower-middle income countries (p=0.0001) but not in upper-middle income countries (p=0.0515) compared to high-income countries. We explained these results as the consequence of the absence of or limited sewage treatment performed in lower income countries. Furthermore, comparison of concentrations of low cost anti-infectives (sulfonamides and trimethoprim) and the more expensive macrolides between income groups suggest that the cost of these substances may have an impact on their environmental occurrence in lower income countries. Since wastewaters are the most important source of contamination of anti-infectives and other

  8. Infections and exposure to anti-infective agents and the risk of severe mental disorders

    DEFF Research Database (Denmark)

    Köhler, Ole; Petersen, Liselotte; Mors, O

    2017-01-01

    OBJECTIVE: Severe infections are associated with increased risks of mental disorders; however, this is the first large-scale study investigating whether infections treated with anti-infective agents in the primary care setting increase the risks of schizophrenia and affective disorders. METHOD: We...

  9. Translational PK/PD of anti-infective therapeutics.

    Science.gov (United States)

    Rathi, Chetan; Lee, Richard E; Meibohm, Bernd

    Translational PK/PD modeling has emerged as a critical technique for quantitative analysis of the relationship between dose, exposure and response of antibiotics. By combining model components for pharmacokinetics, bacterial growth kinetics and concentration-dependent drug effects, these models are able to quantitatively capture and simulate the complex interplay between antibiotic, bacterium and host organism. Fine-tuning of these basic model structures allows to further account for complicating factors such as resistance development, combination therapy, or host responses. With this tool set at hand, mechanism-based PK/PD modeling and simulation allows to develop optimal dosing regimens for novel and established antibiotics for maximum efficacy and minimal resistance development. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. 76 FR 71349 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-11-17

    .... Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration...) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of.... This will include a discussion of the definition and scope of this indication as well as the types of...

  11. 78 FR 22270 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    Science.gov (United States)

    2013-04-15

    ..., indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes... Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug...

  12. 75 FR 47821 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-09

    ... the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (M01- 392), for new drug application (NDA) 20-632, MERIDIA (sibutramine hydrochloride monohydrate) Capsules, sponsored by Abbott Laboratories, for...

  13. 76 FR 23324 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-26

    ... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm... Cardiovascular Risk in Diabetes-Lipid (ACCORD Lipid) trial as they relate to the efficacy and safety of the... cholesterol goal. The ACCORD Lipid study was a randomized, double-blind, placebo- controlled add-on trial...

  14. A review of the clinical implications of anti-infective biomaterials and infection-resistant surfaces.

    Science.gov (United States)

    Campoccia, Davide; Montanaro, Lucio; Arciola, Carla Renata

    2013-11-01

    Infection is currently regarded as the most severe and devastating complication associated to the use of biomaterials. The important social, clinical and economic impacts of implant-related infections are promoting the efforts to obviate these severe diseases. In this context, the development of anti-infective biomaterials and of infection-resistant surfaces is being regarded as the main strategy to prevent the establishment of implant colonisation and biofilm formation by bacteria. In this review, the attention is focused on the biomaterial-associated infections, from which the need for anti-infective biomaterials originates. Biomaterial-associated infections differ markedly for epidemiology, aetiology and severity, depending mainly on the anatomic site, on the time of biomaterial application, and on the depth of the tissues harbouring the prosthesis. Here, the diversity and complexity of the different scenarios where medical devices are currently utilised are explored, providing an overview of the emblematic applicative fields and of the requirements for anti-infective biomaterials. © 2013 Elsevier Ltd. All rights reserved.

  15. The TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development.

    Science.gov (United States)

    Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J; Bushby, Kate

    2015-04-23

    Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a limited numbers of patients who can be enrolled into clinical trials. TREAT-NMD Advisory Committee for Therapeutics (TACT) was established to provide independent and objective guidance on the preclinical and development pathway of potential therapies (whether novel or repurposed) for NMD.We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on a development programme.To date TACT has held 10 review meeting and reviewed 29 program applications in several rare neuromuscular diseases: Of the 29 programs reviewed, 19 were from industry and 10 were from academia; 15 were for novel compounds and 14 were for repurposed drugs; 16 were small molecules and 13 were biologics; 14 were preclinical stage applications and 15 were clinical stage applications. 3 had received Orphan drug designation from European Medicines Agency and 3 from Food and Drug Administration. A number of recurrent themes emerged over the course of the reviews and we found that applicants frequently require advice and education on issues concerned with preclinical standard operating procedures, interactions with regulatory agencies, formulation

  16. Anti-infective bovine colostrum oligosaccharides: Campylobacter jejuni as a case study.

    Science.gov (United States)

    Lane, Jonathan A; Mariño, Karina; Naughton, Julie; Kavanaugh, Devon; Clyne, Marguerite; Carrington, Stephen D; Hickey, Rita M

    2012-07-02

    Campylobacter jejuni is the leading cause of acute bacterial infectious diarrhea in humans. Unlike in humans, C. jejuni is a commensal within the avian host. Heavily colonized chickens often fail to display intestinal disease, and no cellular attachment or invasion has been demonstrated in-vivo. Recently, researchers have shown that the reason for the attenuation of C. jejuni virulence may be attributed to the presence of chicken intestinal mucus and more specifically chicken mucin. Since mucins are heavily glycosylated molecules this observation would suggest that glycan-based compounds may act as anti-infectives against C. jejuni. Considering this, we have investigated naturally sourced foods for potential anti-infective glycans. Bovine colostrum rich in neutral and acidic oligosaccharides has been identified as a potential source of anti-infective glycans. In this study, we tested oligosaccharides isolated and purified from the colostrum of Holstein Friesian cows for anti-infective activity against a highly invasive strain of C. jejuni. During our initial studies we structurally defined 37 bovine colostrum oligosaccharides (BCO) by HILIC-HPLC coupled with exoglycosidase digests and off-line mass spectroscopy, and demonstrated the ability of C. jejuni to bind to some of these structures, in-vitro. We also examined the effect of BCO on C. jejuni adhesion to, invasion of and translocation of HT-29 cells. BCO dramatically reduced the cellular invasion and translocation of C. jejuni, in a concentration dependent manner. Periodate treatment of the BCO prior to inhibition studies resulted in a loss of the anti-infective activity of the glycans suggesting a direct oligosaccharide-bacterial interaction. This was confirmed when the BCO completely prevented C. jejuni binding to chicken intestinal mucin, in-vitro. This study builds a strong case for the inclusion of oligosaccharides sourced from cow's milk in functional foods. However, it is only through further

  17. 77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2012-02-09

    ... symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3- adrenoceptor (AR) agonist and is a new molecular entity. The benefit/ risk discussion will focus on the adequacy of... benefits and risks of mirabegron (YM178), under new drug application (NDA) 202611, submitted by Astellas...

  18. Modulation of Quorum Sensing in a Gram-Positive Pathogen by Linear Molecularly Imprinted Polymers with Anti-infective Properties.

    Science.gov (United States)

    Motib, Anfal; Guerreiro, Antonio; Al-Bayati, Firas; Piletska, Elena; Manzoor, Irfan; Shafeeq, Sulman; Kadam, Anagha; Kuipers, Oscar; Hiller, Luisa; Cowen, Todd; Piletsky, Sergey; Andrew, Peter W; Yesilkaya, Hasan

    2017-12-22

    We describe the development, characterization, and biological testing of a new type of linear molecularly imprinted polymer (LMIP) designed to act as an anti-infective by blocking the quorum sensing (QS) mechanism and so abrogating the virulence of the pathogen Streptococcus pneumoniae. The LMIP is prepared (polymerized) in presence of a template molecule, but unlike in traditional molecular imprinting approaches, no cross-linker is used. This results in soluble low-molecular-weight oligomers that can act as a therapeutic agent in vitro and in vivo. The LMIP was characterized by mass spectrometry to determine its monomer composition. Fragments identified were then aligned along the peptide template by computer modeling to predict the possible monomer sequence of the LMIP. These findings provide a proof of principle that LMIPs can be used to block QS, thus setting the stage for the development of LMIPs a novel drug-discovery platform and class of materials to target Gram-positive pathogens. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. Isolation, Phylogenetic Analysis and Anti-infective Activity Screening of Marine Sponge-Associated Actinomycetes

    Directory of Open Access Journals (Sweden)

    Safwat Ahmed

    2010-02-01

    Full Text Available Terrestrial actinomycetes are noteworthy producers of a multitude of antibiotics, however the marine representatives are much less studied in this regard. In this study, 90 actinomycetes were isolated from 11 different species of marine sponges that had been collected from offshore Ras Mohamed (Egypt and from Rovinj (Croatia. Phylogenetic characterization of the isolates based on 16S rRNA gene sequencing supported their assignment to 18 different actinomycete genera representing seven different suborders. Fourteen putatively novel species were identified based on sequence similarity values below 98.2% to other strains in the NCBI database. A putative new genus related to Rubrobacter was isolated on M1 agar that had been amended with sponge extract, thus highlighting the need for innovative cultivation protocols. Testing for anti-infective activities was performed against clinically relevant, Gram-positive (Enterococcus faecalis, Staphylococcus aureus and Gram-negative (Escherichia coli, Pseudomonas aeruginosa bacteria, fungi (Candida albicans and human parasites (Leishmania major, Trypanosoma brucei. Bioactivities against these pathogens were documented for 10 actinomycete isolates. These results show a high diversity of actinomycetes associated with marine sponges as well as highlight their potential to produce anti-infective agents.

  20. Oligopeptide Targeting Sortase A as Potential Anti-infective Therapy for Staphylococcus aureus

    Directory of Open Access Journals (Sweden)

    Jianfeng Wang

    2018-02-01

    Full Text Available Sortase A (SrtA-catalyzed anchorage of surface proteins in most Gram-positive bacteria is indispensable for their virulence, suggesting that this transpeptidase is a promising target for antivirulence therapy. Here, an oligopeptide, LPRDA, was identified as an effective inhibitor of SrtA via virtual screening based on the LPXTG substrate sequence, and it was found to inhibit SrtA activity in vitro and in vivo (IC50 = 10.61 μM by competitively occupying the active site of SrtA. Further, the oligopeptide treatment had no anti-Staphylococcus aureus activity, but it provided protection against S. aureus-induced mastitis in a mouse model. These findings indicate that the oligopeptide could be used as an effective anti-infective agent for the treatment of infection caused by S. aureus or other Gram-positive bacteria via the targeting of SrtA.

  1. Modulation of Quorum Sensing in a Gram Positive Pathogen by Linear Imprinted Copolymers with anti-Infective Properties

    NARCIS (Netherlands)

    Motib, Anfal; Guerreiro, Antonio; Al-Bayati, Firas; Piletska, Elena; Manzoor, Irfan; Shafeeq, Sulman; Kadam, Anagha; Kuipers, Oscar; Hiller, Luisa; Cowen, Todd; Piletsky, Sergey; Andrew, Peter; Yesilkaya, Hasan

    2017-01-01

    Here we describe the development, characterization and biological testing of a new type of linear molecularly imprinted polymer (LMIP) designed to act as anti-infective by blocking the quorum sensing (QS) mechanism and so preventing virulence of the pathogen Streptococcus pneumoniae. The LMIP is

  2. Delivery of gentamicin from resorbable polymeric carriers as anti-infective strategy for implant-associated osteomyelitis

    NARCIS (Netherlands)

    ter Boo, G.A.

    2016-01-01

    This thesis describes the development of gentamicin loaded resorbable polymeric carriers as anti-infective strategy for implant-associated osteomyelitis and their in vitro and in vivo evaluation. Local delivery of antibiotics has several advantages in the case of trauma to the bone and surrounding

  3. 75 FR 5335 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-02

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... previously issued communications, emphasizing communications challenges. Examples, selected for illustrative...

  4. 76 FR 58519 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-21

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss implications, for strategic communication, of recent theoretical developments on information use...

  5. Biocompatible Silver Nanoparticle-Modified Natural Diatomite with Anti-Infective Property

    Directory of Open Access Journals (Sweden)

    Haolin Sun

    2018-01-01

    Full Text Available Nanosilver as an alternative antibacterial agent of antibiotics has been researched for possible applications in various orthopedic implants. However, it is imperative to achieve controllable release of Ag+ to reduce its cytotoxic effect on normal tissue. Here, a nanosilver release system that has potential to be used in anti-infective bone cement was reported. Nanosilver modified diatomite was developed through the reaction of Tollens’ reagent to improve the antibacterial effect and natural diatomite was used as the carrier of Ag+ ions for controlled release. Cytotoxicity and the antibacterial activities of the nanosilver release system were characterized. After 3 days, the NIH3T3 cells cultured in the extract of nanosilver modified diatomite with an initial concentration of 0.5 mg/ml showed better cell viability than cells cultured in α-MEM. The density of MC3T3-E1 cells cultured in the extract of nanosilver modified diatomite at the same concentration did not differ significantly from the density of cells cultured in α-MEM. The nanosilver modified diatomite exhibited antibacterial effect against E. coli and S. aureus when the concentration was higher than 0.5 mg/ml. With appropriate selection of Ag+ concentration, the nanosilver modified diatomite is promising for improving the antibacterial effect while not affecting the biocompatibility of reinforced calcium phosphate bone cement.

  6. Besifloxacin: a novel anti-infective for the treatment of bacterial conjunctivitis

    Directory of Open Access Journals (Sweden)

    Timothy L Comstock

    2010-03-01

    Full Text Available Timothy L Comstock1, Paul M Karpecki2, Timothy W Morris3, Jin-Zhong Zhang41Global Medical Affairs, Pharmaceuticals, Bausch and Lomb, Inc., Rochester, NY, USA; 2Koffler Vision Group, Lexington, KY, USA; 3Research and Development Microbiology and Sterilization Sciences, Bausch and Lomb, Inc., Rochester, NY, USA; 4Global Preclinical Development, Bausch and Lomb, Inc., Rochester, NY, USAAbstract: Bacterial conjunctivitis, commonly known as pink eye, is demographically unbiased in its prevalence and can be caused by a variety of aerobic and anaerobic bacteria. Timely empiric treatment with a broad-spectrum anti-infective, such as a topical fluoroquinolone, is critical in preventing potentially irreversible ocular damage. However, the rise in ocular methicillin-resistant Staphylococcus aureus isolates and the patterns of fluoroquinolone resistance for patients with other ocular bacterial infections mandate the need for new agents targeted for ocular use. Besifloxacin, a novel broad-spectrum fluoroquinolone, is approved for the treatment of bacterial conjunctivitis. It has a uniquely balanced dual-targeting activity that inhibits both DNA gyrase and topoisomerase IV and is associated with a lower incidence of resistance development. Besifloxacin is not marketed in other formulations, ensuring that its exposure is limited to bacterial populations in and around the eye. This specifically precludes any bacterial exposure to besifloxacin resulting from systemic use, which further reduces the likelihood of emergence of bacterial resistance. In vitro, besifloxacin has demonstrated equivalent or superior activity compared with other commonly used topical antibiotics. In clinical trials, besifloxacin has consistently demonstrated efficacy and safety in the treatment of patients with bacterial conjunctivitis. Besifloxacin is considered safe and is well tolerated with no observed contraindications.Keywords: conjunctivitis, fluoroquinolones, besifloxacin

  7. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-10-26

    ...] Risk Communication Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS... meeting of the Risk Communication Advisory Committee. This meeting was announced in the Federal Register... Communication Advisory Committee would be held on November 8 and 9, 2010. On page 57280, in the first column...

  8. 76 FR 44017 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... and former members of the Risk Communication Advisory Committee. FDA intends to make background...

  9. 76 FR 5380 - Advisory Committees; Filing of Closed Meeting Reports

    Science.gov (United States)

    2011-01-31

    ...] Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION... Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA...), FDA has filed with the Library of Congress the annual reports for the following FDA advisory...

  10. Antimicrobial activity of ceftaroline and other anti-infective agents against microbial pathogens recovered from the surgical intensive care patient population: a prevalence analysis.

    Science.gov (United States)

    Edmiston, Charles E; Krepel, Candace J; Leaper, David; Ledeboer, Nathan A; Mackey, Tami-Lea; Graham, Mary Beth; Lee, Cheong; Rossi, Peter J; Brown, Kellie R; Lewis, Brian D; Seabrook, Gary R

    2014-12-01

    Ceftaroline is a new parenteral cephalosporin agent with excellent activity against methicillin-sensitive (MSSA) and resistant strains of Staphylococcus aureus (MRSA). Critically ill surgical patients are susceptible to infection, often by multi-drug-resistant pathogens. The activity of ceftaroline against such pathogens has not been described. Three hundred thirty-five consecutive microbial isolates were collected from surgical wounds or abscesses, respiratory, urine, and blood cultures from patients in the surgical intensive care unit (SICU) of a major tertiary medical center. Using Clinical and Laboratory Standards Institute (CLSI) standard methodology and published breakpoints, all aerobic, facultative anaerobic isolates were tested against ceftaroline and selected comparative antimicrobial agents. All staphylococcal isolates were susceptible to ceftaroline at a breakpoint of ≤1.0 mcg/mL. In addition, ceftaroline exhibited excellent activity against all streptococcal clinical isolates and non-ESBL-producing strains of Enterobacteriaceae (93.5%) recovered from SICU patients. Ceftaroline was inactive against ESBL-producing Enterobacteriaceae, Pseudomonas aeruginosa, vancomycin-resistant enterococci, and selective gram-negative anaerobic bacteria. At present, ceftaroline is the only cephalosporin agent that is active against community and healthcare-associated MRSA. Further studies are needed to validate the benefit of this novel broad-spectrum anti-infective agent for the treatment of susceptible serious infections in the SICU patient population.

  11. The TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development

    NARCIS (Netherlands)

    Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R.; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M.; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J.; Bushby, Kate; McNeil, Dawn Elizabeth; Allen, Hugh; Bourke, John; Burghes, Arthur; Buyse, Gunnar; Catlin, Nick; Clemens, Paula; Cnaan, Avital; Comi, Giacomo; Connor, Edward; de Luca, Annamaria; de Montleau, Béatrice; de Visser, Marianne; Day, Simon; Dittrich, Sven; Dubrosky, Alberto; Eagle, Michelle; Finkel, Richard; Fishbeck, Kenneth; Furlong, Patricia; Grounds, Miranda; Hauschke, Dieter; Hoffman, Eric; Irwin, Joseph; Jarecki, Jill; Kelly, Michael; Laforêt, Pascal; Lovering, Richard; Larkindale, Jane; Mayer, Henry; McDonald, Robert; McNally, Elizabeth; Miller, Debra; North, Kathryn; Ouillade, Marie-Christine

    2015-01-01

    Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a

  12. 76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012

    Science.gov (United States)

    2011-12-20

    ..., April 30, May 1, August 16-17, November 1-2. Science Board to FDA January 6, May 2, October 3. CENTER... Date(s), if needed, to be Drugs Advisory Committee. determined. Advisory Committee for Pharmaceutical March 14. Science and Clinical Pharmacology. Psychopharmacologic Drugs Advisory Date(s), if needed, to...

  13. 75 FR 80059 - Advisory Committees; Tentative Schedule of Meetings for 2011

    Science.gov (United States)

    2010-12-21

    .... Drugs Advisory Committee. Advisory Committee for Pharmaceutical March 2. Science and Clinical.... Science Board to the Food and Drug February 25, May 20, August 19, Administration. November 10. CENTER FOR... CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board November 9-10. Dated: December 16, 2010. Jill...

  14. Anti-infective properties of the melanin-glucan complex obtained from medicinal tinder bracket mushroom, Fomes fomentarius (L.: Fr.) Fr. (Aphyllophoromycetideae).

    Science.gov (United States)

    Seniuk, Olga F; Gorovoj, Leontiy F; Beketova, Galina V; Savichuk, Hatalia O; Rytik, Petr G; Kucherov, Igor I; Prilutskay, Alla B; Prilutsky, Alexandr I

    2011-01-01

    The goal of this investigation was to comparatively study the efficiency of traditionally used anti-infective drugs and biopolymer complexes originated from the medicinal mushroom Fomes fomentarius (L.:Fr.) Fr.: 1) water-soluble melanin-glucan complex (MGC; -80% melanins and -20% beta-glucans) and 2) insoluble chitin-glucan-melanin complex (ChGMC; -70% chitin, -20% beta-glucans, and -10% melanins). Infectious materials (Helicobacter pylori, Candida albicans, and Herpes vulgaris I and HIV-1(zmb) were used in pure cultures of in vitro and in vivo models on experimental animals. Comparison studies of fungal biopolymers and effective modern antifungal, antibacterial, and antiviral drugs were used in in vitro models. The comparative clinical efficiency of ChGMC and of etiotropic pharmaceuticals in models of H. pylori, C. albicans, and H. vulgaris I infection contamination were studied. Using in vitro models, it was established that MGC completely depresses growth of C. albicans. MGC had an antimicrobial effect on H. pylori identical to erythromycin in all concentrations, and had a stronger action on this bacterium than other tested antibiotics. Tested MGC possesses simultaneously weak toxicity and high anti-HIV-1 activity in comparison with zidovudine (Retrovir). The obtained results show that CLUDDT therapy in Wistar rats with the application of ChGMC is, on average, 1.35-1.43 times as effective as a traditional one. Considering the absence of MGC and ChGMC toxic properties on blood cells even in very high concentrations, these complexes may be used as a source of biopolymers for the creation of essentially new agents for wide application in infectious pathology.

  15. Mussel-inspired alginate gel promoting the osteogenic differentiation of mesenchymal stem cells and anti-infection

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Shiwen [Department of Mechanical Engineering, Faculty of Engineering and Department of Biochemistry & Genetics, Faculty of Medicine and Manitoba Institute of Child Health, The University of Manitoba, Winnipeg, Manitoba (Canada); Children Hospital Research Institute of Manitoba, Winnipeg (Canada); Sichuan University, Chengdu (China); Xu, Kaige; Darabi, Mohammad Ali [Children Hospital Research Institute of Manitoba, Winnipeg (Canada); Yuan, Quan [Sichuan University, Chengdu (China); Xing, Malcolm [Department of Mechanical Engineering, Faculty of Engineering and Department of Biochemistry & Genetics, Faculty of Medicine and Manitoba Institute of Child Health, The University of Manitoba, Winnipeg, Manitoba (Canada)

    2016-12-01

    Alginate hydrogels have been used in cell encapsulation for many years but a prevalent issue with pure alginates is that they are unable to provide enough bioactive properties to interact with mammalian cells. This paper discusses the modification of alginate with mussel-inspired dopamine for cell loading and anti-infection. Mouse bone marrow stem cells were immobilized into alginate and alginate-dopamine beads and fibers. Through live-dead and MTT assay, alginates modified by dopamine promoted cell viability and proliferation. In vitro cell differentiation results showed that such an alginate-dopamine gel can promote the osteogenic differentiation of mesenchymal stem cell after PCR and ALP assays. In addition to that, the adhesive prosperities of dopamine allowed for coating the surface of alginate-dopamine gel with silver nanoparticles, which provided the gel with significant antibacterial characteristics. Overall, these results demonstrate that a dopamine-modified alginate gel can be a great tool for cell encapsulation to promote cell proliferation and can be applied to bone regeneration, especially in contaminated bone defects. - Highlights: • Dopamine modified alginate bead and fiber promote cell viability and proliferation. • Alginate-dopamine gel promotes osteogenic differentiation of MSCs. • Dopamine reduced nanosilver for anti-infection. • Alginate-dopamine bead and fiber for delivery of mesenchymal stem cells (MSCs)

  16. Effect of Winemaking on the Composition of Red Wine as a Source of Polyphenols for Anti-Infective Biomaterials

    Directory of Open Access Journals (Sweden)

    Arianna Di Lorenzo

    2016-04-01

    Full Text Available Biomaterials releasing bactericides have currently become tools for thwarting medical device-associated infections. The ideal anti-infective biomaterial must counteract infection while safeguarding eukaryotic cell integrity. Red wine is a widely consumed beverage to which many biological properties are ascribed, including protective effects against oral infections and related bone (osteoarthritis, osteomyelitis, periprosthetic joint infections and cardiovascular diseases. In this study, fifteen red wine samples derived from grapes native to the Oltrepò Pavese region (Italy, obtained from the winemaking processes of “Bonarda dell’Oltrepò Pavese” red wine, were analyzed alongside three samples obtained from marc pressing. Total polyphenol and monomeric anthocyanin contents were determined and metabolite profiling was conducted by means of a chromatographic analysis. Antibacterial activity of wine samples was evaluated against Streptococcus mutans, responsible for dental caries, Streptococcus salivarius, and Streptococcus pyogenes, two oral bacterial pathogens. Results highlighted the winemaking stages in which samples exhibit the highest content of polyphenols and the greatest antibacterial activity. Considering the global need for new weapons against bacterial infections and alternatives to conventional antibiotics, as well as the favorable bioactivities of polyphenols, results point to red wine as a source of antibacterial substances for developing new anti-infective biomaterials and coatings for biomedical devices.

  17. Mussel-inspired alginate gel promoting the osteogenic differentiation of mesenchymal stem cells and anti-infection

    International Nuclear Information System (INIS)

    Zhang, Shiwen; Xu, Kaige; Darabi, Mohammad Ali; Yuan, Quan; Xing, Malcolm

    2016-01-01

    Alginate hydrogels have been used in cell encapsulation for many years but a prevalent issue with pure alginates is that they are unable to provide enough bioactive properties to interact with mammalian cells. This paper discusses the modification of alginate with mussel-inspired dopamine for cell loading and anti-infection. Mouse bone marrow stem cells were immobilized into alginate and alginate-dopamine beads and fibers. Through live-dead and MTT assay, alginates modified by dopamine promoted cell viability and proliferation. In vitro cell differentiation results showed that such an alginate-dopamine gel can promote the osteogenic differentiation of mesenchymal stem cell after PCR and ALP assays. In addition to that, the adhesive prosperities of dopamine allowed for coating the surface of alginate-dopamine gel with silver nanoparticles, which provided the gel with significant antibacterial characteristics. Overall, these results demonstrate that a dopamine-modified alginate gel can be a great tool for cell encapsulation to promote cell proliferation and can be applied to bone regeneration, especially in contaminated bone defects. - Highlights: • Dopamine modified alginate bead and fiber promote cell viability and proliferation. • Alginate-dopamine gel promotes osteogenic differentiation of MSCs. • Dopamine reduced nanosilver for anti-infection. • Alginate-dopamine bead and fiber for delivery of mesenchymal stem cells (MSCs)

  18. 75 FR 11551 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-11

    ...] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General... Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive...

  19. 77 FR 70450 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-26

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... 1. Contact Person: Lee L. Zwanziger, Risk Communication Staff, Food and Drug Administration, 10903...

  20. 77 FR 62242 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-12

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Person: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration...

  1. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  2. 76 FR 42715 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  3. 77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  4. 77 FR 1697 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  5. 78 FR 33423 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee...

  6. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-28

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...

  7. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...

  8. Trends in Mode of Hysterectomy After the U.S. Food and Drug Administration Power Morcellation Advisory.

    Science.gov (United States)

    Ottarsdottir, Helga; Cohen, Sarah L; Cox, Mary; Vitonis, Allison; Einarsson, Jon I

    2017-06-01

    To evaluate the trends in mode of surgery for benign hysterectomy after the 2014 U.S. Food and Drug Administration (FDA) morcellation guidelines. This is a retrospective review of all patients who underwent a hysterectomy for benign indications, specifically for leiomyomas, at Brigham and Women's Hospital from 2013 to 2015. The rates of abdominal, vaginal, laparoscopic, and robotic-assisted laparoscopic hysterectomy as well as the perioperative outcomes were compared over the study period. Analysis was performed using multivariable linear, multinomial, and logistic regression. Regression models were adjusted for potential confounders. From 2013 to 2015, 1,530 patients underwent a hysterectomy for benign indications and 639 patients underwent the procedure for the indication of uterine leiomyomas; there was a decrease in the number of hysterectomy cases in the later years. Focusing on the patients with leiomyomas alone, there was a 40-60% decreased odds of a minimally invasive procedure in 2014 or 2015 compared with 2013 [adjusted odds ratio (OR) 0.53 (0.29-0.97) in 2014 and adjusted OR 0.40 (0.22-0.74) in 2015, P=.003]. A 24% decrease in the supracervical approach to hysterectomy was also noted. Despite these trends, the majority of cases in each year were still performed in a minimally invasive fashion. The factor most strongly associated with undergoing a minimally invasive hysterectomy was having a fellowship-trained surgeon perform the procedure [adjusted OR 6.80 (3.65-12.7), P<.001]. There was no significant difference between the year of surgery and occurrence of intraoperative complications or reoperation. Although key perioperative outcomes remained similar, the overall rate of minimally invasive surgery declined at our institution after the FDA's recommendations. With changing practice patterns and vigilance surrounding power morcellation, gynecologic surgeons may still offer patients minimally invasive procedures with all of the accompanying advantages.

  9. 77 FR 65693 - Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2012-10-30

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. This meeting was... announced that a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee would be held on...

  10. [Systemic therapy with anti-infective agents. Principles of rational use of systemic antibiotics in dermatology].

    Science.gov (United States)

    Sunderkötter, C; Brehler, R; Becker, K

    2014-02-01

    Antibiotics are frequently prescribed and extremely valuable drugs, because they are curative. However, their often incorrect use is the main reason for the increase of multiresistant pathogens. Inappropriate prescription of broad spectrum antibiotics for skin and soft tissue infections favors the selection and spread of multiresistant bacteria not only in the skin, but also in remote visceral organs (e.g. in the intestines), due to their systemic distribution and effects in the body (so-called collateral damage). For this reason basic knowledge and special prudence when using antibiotics are just as desirable as an awareness of responsibility for the public welfare. This article intends to convey basic knowledge on the indications and selection of suitable antibiotics as well as on the development of bacterial resistance and it gives recommendations for allergological procedures when patients report alleged drug reactions to antibiotics. Systemic antibiotics for soft tissue infections are indicated when the infection spreads within the tissue so that it is no longer accessible for local antiseptics. In addition to the clinical symptoms, important parameters are high blood sedimentation rates (BSR) and high levels of C-reactive protein (CRP), leukocytosis with neutrophilia and fever (not always present in elderly or immunosuppressed patients). Certain constellations, such as the presence of severe underlying diseases, perfusion disorders or a particular localization (e.g. infection of the face) may necessitate early or parenteral administration. There is no need for systemic administration of antibiotics for uncomplicated wounds without soft tissue infections. Due to their curative effects, the decisive criterion for the use of antibiotics is their sufficient antimicrobial efficacy at the site of infection. An inappropriate administration increases both the selection pressure and costs of treatment and can have fatal consequences in serious situations. In

  11. Anti-infective properties of Lactobacillus fermentum against Staphylococcus aureus and Pseudomonas aeruginosa.

    Science.gov (United States)

    Varma, Parvathi; Nisha, N; Dinesh, Kavitha R; Kumar, Anil V; Biswas, Raja

    2011-01-01

    Surgical wounds and implant-associated Staphylococcus aureus and Pseudomonas aeruginosa infections are often difficult to treat because of limited susceptibility of several of these strains to conventional antibiotics. As a result, there is a constant need for new alternative drugs. The aim of this study was to investigate the antimicrobial properties of Lactobacillus fermentum, a probiotic bacterium, which we have isolated from colonic biopsies. The inhibition of S. aureus and P. aeruginosa growth was evaluated by coincubating with L. fermentum strains. Growth inhibition was tested for several of their clinical isolates using agar well diffusion assays. For biofilm assay S. aureus and P. aeruginosa were grown on the glass slides and in 96-well plates in presence of 2.5 μg/ml culture filtrate of L. fermentum. Biofilms were photographed using confocal microscope or stained with 0.1% crystal violet. Reduction in the cytotoxicity of S. aureus and P. aeruginosa was observed in presence of 2.5 μg/ml L. fermentum-spent media. Using in vitroexperiments, we showed that L. fermentum-secreted compound(s) inhibits the growth, cytotoxicity and biofilm formation of several S. aureus and P. aeruginosa strains. Compound(s) present in the culture supernatant of L. fermentum may have promising applications in treating hospital-acquired infections. Copyright © 2011 S. Karger AG, Basel.

  12. Anti-infective efficacy of the lactoferrin-derived antimicrobial peptide HLR1r.

    Science.gov (United States)

    Björn, Camilla; Mahlapuu, Margit; Mattsby-Baltzer, Inger; Håkansson, Joakim

    2016-07-01

    Antimicrobial peptides (AMPs) have emerged as a new class of drug candidates for the treatment of infectious diseases. Here we describe a novel AMP, HLR1r, which is structurally derived from the human milk protein lactoferrin and demonstrates a broad spectrum microbicidal action in vitro. The minimum concentration of HLR1r needed for killing ≥99% of microorganisms in vitro, was in the range of 3-50μg/ml for common Gram-negative and Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), and for the yeast Candida albicans, when assessed in diluted brain-heart infusion medium. We found that HLR1r also possesses anti-inflammatory properties as evidenced by inhibition of tumor necrosis factor alpha (TNF-α) secretion from human monocyte-derived macrophages and by repression of interleukin-6 (IL-6) and plasminogen activator inhibitor-1 (PAI-1) secretion from human mesothelial cells, without any cytotoxic effect observed at the concentration range tested (up to 400μg/ml). HLR1r demonstrated pronounced anti-infectious effect in in vivo experimental models of cutaneous candidiasis in mice and of excision wounds infected with MRSA in rats as well as in an ex vivo model of pig skin infected with S. aureus. In conclusion, HLR1r may constitute a new therapeutic alternative for local treatment of skin infections. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Genetic and chemical knockdown: a complementary strategy for evaluating an anti-infective target

    Directory of Open Access Journals (Sweden)

    Ramachandran V

    2013-02-01

    Full Text Available Vasanthi Ramachandran,1,* Ragini Singh,2,* Xiaoyu Yang,1 Ragadeepthi Tunduguru,1 Subrat Mohapatra,2 Swati Khandelwal,2 Sanjana Patel,2 Santanu Datta21AstraZeneca India R&D, Bangalore, India; 2Cellworks India, Bangalore, India *These authors contributed equally to this workAbstract: The equity of a drug target is principally evaluated by its genetic vulnerability with tools ranging from antisense- and microRNA-driven knockdowns to induced expression of the target protein. In order to upgrade the process of antibacterial target identification and discern its most effective type of inhibition, an in silico toolbox that evaluates its genetic and chemical vulnerability leading either to stasis or cidal outcome was constructed and validated. By precise simulation and careful experimentation using enolpyruvyl shikimate-3-phosphate synthase and its specific inhibitor glyphosate, it was shown that genetic knockdown is distinct from chemical knockdown. It was also observed that depending on the particular mechanism of inhibition, viz competitive, uncompetitive, and noncompetitive, the antimicrobial potency of an inhibitor could be orders of magnitude different. Susceptibility of Escherichia coli to glyphosate and the lack of it in Mycobacterium tuberculosis could be predicted by the in silico platform. Finally, as predicted and simulated in the in silico platform, the translation of growth inhibition to a cidal effect was able to be demonstrated experimentally by altering the carbon source from sorbitol to glucose.Keywords: knockdown, inhibition, in silico, vulnerability

  14. INFECTIOUS AETIOLOGY OF MARGINAL ZONE LYMPHOMA AND ROLE OF ANTI-INFECTIVE THERAPY

    Directory of Open Access Journals (Sweden)

    Salvatore Perrone

    2016-01-01

    Full Text Available Marginal zone lymphomas have been associated with several infectious agents covering both viral and bacterial pathogens and in some cases a clear aetiological role has been established. Pathogenetic mechanisms are currently not completely understood, however the role of chronic stimulation of the host immune response with persistent lymphocyte activation represents the most convincing explanation for lymphoproliferation. Gastric MALT lymphoma is strictly associated with Helicobacter pylori infection and various eradicating protocols, developed due to increasing antibiotic resistance, represent the first line therapy. The response rate to eradication is good with 80% of response at 1 year; this finding is also noteworthy because recapitulates a cancer cured only by antibacterial approach and it satisfies the Koch postulates of causation, establishing a causative relationship between Hp and gastric MALT lymphoma. Patients with chronic HCV infection have 5 times higher risk to develop MZL, in particular an association with splenic and nodal MZL has been shown in several studies. Moreover, there is evidence of lymphoma regression after antiviral therapy with interferon+ribavirin, thus rising hope that new available drugs, extremely effective against HCV replication, could improve outcome also in HCV-driven lymphomas. The rare cases of MZL localized to orbital fat and eye conjunctivas have been associated with Chlamydia psittaci infection carried by birds. Efficacy of antibacterial therapy against C. psittaci are conflicting and generally poorer thain gastric MALT. Finally some case-reports will cover the relationship between primary cutaneous B-cell Lymphomas and Borrelia Burgdorferi.

  15. The quest for anti-inflammatory and anti-infective biomaterials in clinical translation

    Directory of Open Access Journals (Sweden)

    May Griffith

    2016-09-01

    Full Text Available Biomaterials are now being used or evaluated clinically as implants to supplement the severe shortage of available human donor organs. To date however, such implants have mainly been developed as scaffolds to promote the regeneration of failing organs due to old age or congenital malformations. In the real world, however, infection or immunological issues often compromise patients. For example, bacterial and viral infections can result in uncontrolled immunopathological damage and lead to organ failure. Hence, there is a need for biomaterials and implants that not only promote regeneration but also address issues that are specific to compromised patients such as infection and inflammation. Different strategies are needed to address the regeneration of organs that have been damaged by infection or inflammation for successful clinical translation. Therefore, the real quest is for multi-functional biomaterials with combined properties that can combat infections, modulate inflammation and promote regeneration at the same time. These strategies will necessitate the inclusion of methodologies for management of the cellular and signaling components elicited within the local microenvironment. In the development of such biomaterials, strategies range from the inclusion of materials that have intrinsic anti-inflammatory properties, such as the synthetic lipid polymer, 2-methacryloyloxyethyl phosphorylcholine (MPC, to silver nanoparticles that have anti-bacterial properties, to inclusion of nano- and micro-particles in biomaterials composites that deliver active drugs. In this present review, we present examples of both kinds of materials in each group along with their pros and cons. Thus, as a promising next generation strategy to aid or replace tissue/organ transplantation, an integrated smart programmable platform is needed for regenerative medicine applications to create and/or restore normal function at the cell and tissue levels. Therefore, now it is

  16. Anti-infective effects of Brazilian Caatinga plants against pathogenic bacterial biofilm formation.

    Science.gov (United States)

    Silva, Laura Nunes; Trentin, Danielle da Silva; Zimmer, Karine Rigon; Treter, Janine; Brandelli, Clara Lia Costa; Frasson, Amanda Piccoli; Tasca, Tiana; da Silva, Alexandre Gomes; da Silva, Márcia Vanusa; Macedo, Alexandre José

    2015-03-01

    The local communities living in the Brazilian Caatinga biome have a significant body of traditional knowledge on a considerable number of medicinal plants used to heal several maladies. Based on ethnopharmacological data, this study screened 23 aqueous plant extracts against two well-known models of biofilm-forming bacteria: Staphylococcus epidermidis and Pseudomonas aeruginosa. Crystal violet assay and scanning electron microscopy (SEM) were used to evaluate the effect of extracts on biofilm formation and measurements of the absorbance at 600 nm to assess bacterial growth. Selected extracts were investigated regarding the cytotoxicity by MTT assay using mammal cells and the qualitative phytochemical fingerprint by thin layer chromatography. Harpochilus neesianus Mart. ex Nees. (Acanthaceae) leaves, Apuleia leiocarpa Vogel J. F. Macbr. (Fabaceae), and Poincianella microphylla Mart. ex G. Don L. P. Queiroz (Fabaceae) fruits showed non-biocidal antibiofilm action against S. epidermidis with activities of 69, 52, and 63%, respectively. SEM confirmed that biofilm structure was strongly prevented and that extracts promoted overproduction of the matrix and/or bacterial morphology modification. Poincianella microphylla demonstrated toxicity at 4.0 mg/mL and 2.0 mg/mL, A. leiocarpa presented toxicity only at 4.0 mg/mL, whereas H. neesianus presented the absence of toxicity against Vero cell line. Preliminary phytochemical analysis revealed the presence of flavonoids, terpenoids, steroids, amines, and polyphenols. This work provides a scientific basis which may justify the ethnopharmacological use of the plants herein studied, indicating extracts that possess limited mammal cytotoxicity in vitro and a high potential as a source of antibiofilm drugs prototypes.

  17. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Science.gov (United States)

    2011-08-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the Arthritis Advisory...

  18. 75 FR 57279 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Committee will hear and discuss developments in FDA's ongoing communications programs, such as FDA's...

  19. 76 FR 16427 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-23

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... discuss developments in FDA's ongoing communications programs. The discussion will focus on the use of...

  20. 75 FR 20608 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-20

    ...] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communication Advisory Committee. General Function of the Committee: To provide advice and recommendations to... relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of...

  1. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... indication: ``ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to...

  2. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-30

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee..., the committee will discuss the Assessment of SpondyloArthritis international Society classification...

  3. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-12

    ...] Arthritis Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Administration (FDA). The meeting will be open to the public. Name of Committee: Arthritis Advisory Committee... the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had...

  4. 75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-26

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

  5. Preparation of ZnO/Ag nanocomposite and coating on polymers for anti-infection biomaterial application.

    Science.gov (United States)

    Sadeghi, Babak

    2014-01-24

    ZnO/Ag nanocomposites coated with polyvinyl chloride (PVC) were prepared by chemical reduction method, for anti-infection biomaterial application. There is a growing interest in attempts in using biomolecular as the templates to grow inorganic nanocomposites in controlled morphology and structure. By optimizing the experiment conditions, we successfully fabricated high yield of ZnO/Ag nanocomposite with full coverage of high-density polyvinyl chloride (PVC) coating. More importantly, ZnO/Ag nanocomposites were shown to significantly inhibit the growth of Staphylococcus aureus in solution. It was further shown that ZnO/Ag nanocomposites induced thiol depletion that caused death of S. aureus. The coatings were fully characterized using techniques such as scanning electron microscopy (SEM), transmission electron microscopy (TEM) and X-ray diffraction (XRD). Most importantly, compared to uncoated metals, the coatings on PVC promoted healthy antibacterial activity. Importantly, compared to ZnO-Ag -uncoated PVC, the ZnO/Ag nanocomposites coated was approximately triplet more effective in preventing bacteria attachment. The result of Thermal Gravimetric Analysis (TGA) indicates that, the ZnO/Ag nanocomposites are chemically stable in the temperature range from 50 to 900°C. This result, for the first time, demonstrates the potential of using ZnO/Ag nanocomposites as a coating material for numerous anti-bacterial applications. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Comblike poly(ethylene oxide)/hydrophobic C6 branched chitosan surfactant polymers as anti-infection surface modifying agents.

    Science.gov (United States)

    Mai-ngam, Katanchalee

    2006-05-01

    A series of structurally well-defined poly(ethylene oxide)/hydrophobic C6 branched chitosan surfactant polymers that undergo surface induced self assembly on hydrophobic biomaterial surfaces were synthesized and characterized. The surfactant polymers consist of low molecular weight (Mw) chitosan backbone with hydrophilic poly(ethylene oxide) (PEO) and hydrophobic hexyl pendant groups. Chitosan was depolymerized by nitrous acid deaminative cleavage. Hexanal and aldehyde-terminated PEO chains were simultaneously attached to low Mw chitosan hydrochloride via reductive amination. The surfactant polymers were prepared with various ratios of the two side chains. The molecular composition of the surfactant polymers was determined by FT-IR and 1H NMR. Surface active properties at the air-water interface were determined by Langmuir film balance measurements. The surfactant polymers with PEO/hexyl ratios of 1:3.0 and 1:14.4 were used as surface modifying agents to investigate their anti-infection properties. E. coli adhesion on Silastic surface was decreased significantly by the surfactant polymer with PEO/hexyl 1:3.0. Surface growth of adherent E. coli was effectively suppressed by both tested surfactant polymers.

  7. 21 CFR 14.95 - Compensation of advisory committee members.

    Science.gov (United States)

    2010-04-01

    ... employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Compensation of advisory committee members. 14.95 Section 14.95 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  8. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Science.gov (United States)

    2013-11-22

    .... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...

  9. Anti-infective efficacy, cytocompatibility and biocompatibility of a 3D-printed osteoconductive composite scaffold functionalized with quaternized chitosan.

    Science.gov (United States)

    Yang, Ying; Yang, Shengbing; Wang, Yugang; Yu, Zhifeng; Ao, Haiyong; Zhang, Hongbo; Qin, Ling; Guillaume, Olivier; Eglin, David; Richards, R Geoff; Tang, Tingting

    2016-12-01

    activity and biocompatibility. Therefore, it provides an effective porous composite scaffold to combat the infected bone defect in clinic with decreased risks of bacterial resistance and open a feasible strategy for the modification of scaffold interfaces involved in the bone regeneration and anti-infection. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  10. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  11. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  12. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

  13. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  14. 76 FR 49774 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  15. 76 FR 64951 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide...

  16. 78 FR 15726 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-03-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of...

  17. Drug prescriptions in Danish out-of-hours primary care

    DEFF Research Database (Denmark)

    Christensen, Morten Bondo; Nørøxe, Karen Busk; Moth, Grete

    2016-01-01

    of prescriptions per 100 contacts. RESULTS: Of 644,777 contacts, 154,668 (24.0%) involved medication prescriptions; 21.9% of telephone consultations, 32.9% of clinic consultations and 14.3% of home visits. Around 53% of all drug prescriptions were made in telephone consultations. Anti-infective medications...... for systemic use accounted for 45.5% of all prescriptions and were the most frequently prescribed drug group for all contact types, although accounting for less than 1/3 of telephone prescriptions. Other frequently prescribed drugs were ophthalmological anti-infectives (10.5%), NSAIDs (6.4%), opioids (3......) primary care services cover more than 75% of all hours during a normal week, insight into the extent and type of OOH drug prescription is important. General practitioners (GPs) are responsible for more than 80% of all drug prescriptions in Denmark. Of all contacts 24.0% involved medication prescriptions...

  18. The influence of anti-infective periodontal treatment on C-reactive protein: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ryan T Demmer

    Full Text Available Periodontal infections are hypothesized to increase the risk of adverse systemic outcomes through inflammatory mechanisms. The magnitude of effect, if any, of anti-infective periodontal treatment on systemic inflammation is unknown, as are the patient populations most likely to benefit. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs to test the hypothesis that anti-infective periodontal treatment reduces systemic c-reactive protein (CRP.MEDLINE, EMBASE, CENTRAL and CINAHL databases were searched using sensitivity-enhancing search terms. Eligible RCTs enrolled patients with periodontal infection, compared a clearly defined anti-infective periodontal intervention (experimental group to an "inactive control" (no periodontal intervention or to an "active control" (lower treatment intensity than the experimental group. Mean differences in final CRP values at the earliest post-treatment time point (typically 1-3 months between experimental and control groups were analyzed using random-effects regression. Among 2,753 possible studies 20 were selected, which included 2,561 randomized patients(median=57. Baseline CRP values were >3.0 mg/L in 40% of trials. Among studies with a control group receiving no treatment, the mean difference in CRP final values among experimental treatment vs. control groups was -0.37 mg/L [95%CI=-0.64, -0.11], (P=0.005, favoring experimental treatment. Trials for which the experimental group received antibiotics had stronger effects (P for interaction=0.03 and the mean difference in CRP final values among experimental treatment vs. control was -0.75 mg/L [95%CI=-1.17,-0.33]. No treatment effect was observed among studies using an active treatment comparator. Treatment effects were stronger for studies that included patients with co-morbidities vs. studies that included "systemically healthy" patients, although the interaction was not significant (P=0.48.Anti-infective periodontal

  19. Advisory Committee Handbook.

    Science.gov (United States)

    Black Hawk Coll., Moline, IL.

    An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…

  20. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to ... 2005 –Ongoing Behaviors associated with drug misuse are among the main ...

  1. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-11-27

    ... awareness and understanding of the key risk messages, as well as whether the communications are having the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS...

  2. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-03-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

  3. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-11-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

  4. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-13

    ...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

  5. 78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-08

    ...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...

  6. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    2011-09-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

  7. 78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-02

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...

  8. 77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-18

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...

  9. 77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-25

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

  10. 75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-28

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the...

  11. 77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-17

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide...) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet...

  12. 78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-05

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

  13. 76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-14

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review...

  14. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...

  15. 76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-07

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...

  16. 76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-20

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update...

  17. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-25

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...

  18. 76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-22

    ...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...

  19. 78 FR 44133 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-07-23

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and...

  20. 76 FR 22405 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-21

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide... June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of...

  1. 78 FR 79699 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-31

    ...] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide... updates on guidance documents issued from the Office of Cellular, Tissue, and Gene Therapies, Center for...

  2. 75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  3. 76 FR 3912 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  4. 78 FR 42966 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-07-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  5. 77 FR 41790 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  6. 77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  7. 77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2012-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  8. 75 FR 8368 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

  9. VSWI Wetlands Advisory Layer

    Data.gov (United States)

    Vermont Center for Geographic Information — This dataset represents the DEC Wetlands Program's Advisory layer. This layer makes the most up-to-date, non-jurisdictional, wetlands mapping avaiable to the public...

  10. 75 FR 43156 - Federal Advisory Committee; Missile Defense Advisory Committee

    Science.gov (United States)

    2010-07-23

    ... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Missile Defense Advisory Committee AGENCY: Missile Defense Agency (MDA), DoD. ACTION: Notice of closed meeting. SUMMARY: Under the... Defense announces that the Missile Defense Advisory Committee will meet on August 4 and 5, 2010, in...

  11. Quercetin-loaded PLGA nanoparticles: a highly effective antibacterial agent in vitro and anti-infection application in vivo

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Dongdong; Li, Nuan; Zhang, Weiwei; Yang, Endong; Mou, Zhipeng; Zhao, Zhiwei; Liu, Haiping; Wang, Weiyun, E-mail: weiywswzy@163.com [Anhui Agricultural University, School of Life Sciences (China)

    2016-01-15

    Nanotechnology-based approaches have tremendous potential for enhancing efficacy against infectious diseases. PLGA-based nanoparticles as drug delivery carrier have shown promising potential, owing to their sizes and related unique properties. This article aims to develop nanosized poly (d, l-lactide-co-glycolide) PLGA nanoparticle formulation loaded with quercetin (QT). QT is an antioxidant and antibacterial compound isolated from Chinese traditional medicine with low skin permeability and extreme water insolubility. The quercetin-loaded PLGA nanoparticles (PQTs) were synthesized by emulsion–solvent evaporation method and stabilized by coating with poly (vinyl alcohol). The characteristics of PQTs were analyzed by Fourier transform infrared spectroscopy, Ultraviolet–Visible spectroscopy, scanning electron microscope, transmission electron microscopy, and atomic force microscopy, respectively. The PQTs showed a spherical shape with an average size of 100–150 nm. We compared the antibacterial effects of PQTs against Escherichia coli (E. coli) and Micrococcus tetragenus (M. tetragenus).The PQTs produced stronger antibacterial activity to E. coli than that to M. tetragenus through disrupting bacterial cell wall integrity. The antibacterial ratio was increased with the increasing dosages and incubation time. Next, we tested the in vivo antibacterial activity in mice. No noticeable organ damage was captured from H&E-staining organ slices, suggesting the promise of using PQTs for in vivo applications. The results of this study demonstrated the interaction between bacteria and PLGA-based nanoparticles, providing encouragement for conducting further investigations on properties and antimicrobial activity of the PQTs in clinical application.

  12. Quercetin-loaded PLGA nanoparticles: a highly effective antibacterial agent in vitro and anti-infection application in vivo

    International Nuclear Information System (INIS)

    Sun, Dongdong; Li, Nuan; Zhang, Weiwei; Yang, Endong; Mou, Zhipeng; Zhao, Zhiwei; Liu, Haiping; Wang, Weiyun

    2016-01-01

    Nanotechnology-based approaches have tremendous potential for enhancing efficacy against infectious diseases. PLGA-based nanoparticles as drug delivery carrier have shown promising potential, owing to their sizes and related unique properties. This article aims to develop nanosized poly (d, l-lactide-co-glycolide) PLGA nanoparticle formulation loaded with quercetin (QT). QT is an antioxidant and antibacterial compound isolated from Chinese traditional medicine with low skin permeability and extreme water insolubility. The quercetin-loaded PLGA nanoparticles (PQTs) were synthesized by emulsion–solvent evaporation method and stabilized by coating with poly (vinyl alcohol). The characteristics of PQTs were analyzed by Fourier transform infrared spectroscopy, Ultraviolet–Visible spectroscopy, scanning electron microscope, transmission electron microscopy, and atomic force microscopy, respectively. The PQTs showed a spherical shape with an average size of 100–150 nm. We compared the antibacterial effects of PQTs against Escherichia coli (E. coli) and Micrococcus tetragenus (M. tetragenus).The PQTs produced stronger antibacterial activity to E. coli than that to M. tetragenus through disrupting bacterial cell wall integrity. The antibacterial ratio was increased with the increasing dosages and incubation time. Next, we tested the in vivo antibacterial activity in mice. No noticeable organ damage was captured from H&E-staining organ slices, suggesting the promise of using PQTs for in vivo applications. The results of this study demonstrated the interaction between bacteria and PLGA-based nanoparticles, providing encouragement for conducting further investigations on properties and antimicrobial activity of the PQTs in clinical application

  13. Quercetin-loaded PLGA nanoparticles: a highly effective antibacterial agent in vitro and anti-infection application in vivo

    Science.gov (United States)

    Sun, Dongdong; Li, Nuan; Zhang, Weiwei; Yang, Endong; Mou, Zhipeng; Zhao, Zhiwei; Liu, Haiping; Wang, Weiyun

    2016-01-01

    Nanotechnology-based approaches have tremendous potential for enhancing efficacy against infectious diseases. PLGA-based nanoparticles as drug delivery carrier have shown promising potential, owing to their sizes and related unique properties. This article aims to develop nanosized poly ( d, l-lactide-co-glycolide) PLGA nanoparticle formulation loaded with quercetin (QT). QT is an antioxidant and antibacterial compound isolated from Chinese traditional medicine with low skin permeability and extreme water insolubility. The quercetin-loaded PLGA nanoparticles (PQTs) were synthesized by emulsion-solvent evaporation method and stabilized by coating with poly (vinyl alcohol). The characteristics of PQTs were analyzed by Fourier transform infrared spectroscopy, Ultraviolet-Visible spectroscopy, scanning electron microscope, transmission electron microscopy, and atomic force microscopy, respectively. The PQTs showed a spherical shape with an average size of 100-150 nm. We compared the antibacterial effects of PQTs against Escherichia coli ( E. coli) and Micrococcus tetragenus ( M. tetragenus).The PQTs produced stronger antibacterial activity to E. coli than that to M. tetragenus through disrupting bacterial cell wall integrity. The antibacterial ratio was increased with the increasing dosages and incubation time. Next, we tested the in vivo antibacterial activity in mice. No noticeable organ damage was captured from H&E-staining organ slices, suggesting the promise of using PQTs for in vivo applications. The results of this study demonstrated the interaction between bacteria and PLGA-based nanoparticles, providing encouragement for conducting further investigations on properties and antimicrobial activity of the PQTs in clinical application.

  14. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture

    Directory of Open Access Journals (Sweden)

    Bate R

    2012-07-01

    Full Text Available Roger Bate,1 Lorraine Mooney,2 Kimberly Hess,3 Julissa Milligan,1 Amir Attaran41American Enterprise Institute, Washington DC, USA; 2Africa Fighting Malaria, London, UK; 3Africa Fighting Malaria, Washington DC, USA; 4Faculty of Law and Medicine, University of Ottawa, Ottawa, CanadaBackground: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA or the World Health Organization (WHO prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either.Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab® protocol to identify whether they were substandard, degraded, or counterfeit.Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50% than Indian cities (26.57%, but they also experienced a higher failure rate (14.21% than Indian cities (7.83%. The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed.Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high

  15. Use of human immunoglobulins as an anti-infective treatment: the experience so far and their possible re-emerging role.

    Science.gov (United States)

    Bozzo, Jordi; Jorquera, Juan I

    2017-06-01

    Pooled human immunoglobulins (IGs) are prepared from plasma obtained from healthy donors as a concentrated antibody-containing solution. In addition, high-titer IGs (hyperimmune) against a specific pathogen can be obtained from vaccinated or convalescing donors. Currently, IGs can be used for the treatment of a variety of infections for which no specific therapy exists or that remain difficult to treat. Moreover, the recent pathogen outbreaks for which there is no approved treatment have renewed attention to the role of convalescent plasma and IGs. Areas covered: In this review, a historical perspective of the use of sera and IGs in humans as anti-infective agents (any viral, bacterial, parasitic infection), excluding immunodeficient patients, is presented from early development to the latest clinical studies. A Medline search was conducted to examine the peer-reviewed literature, with no date limits. Expert commentary: Human pooled plasma-derived IG products benefit from the polyclonal response of every individual donor and from the interindividual variability in such response. The trend to increased availability of vaccines for infectious diseases also opens new potential applications of hyperimmune IGs for emerging or re-emerging infectious diseases (e.g.: Ebola, Zika, Dengue), for the prevention and treatment in the general population, healthcare personnel and caregivers.

  16. 21 CFR 14.155 - Fees and compensation pertaining to a color additive advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees and compensation pertaining to a color additive advisory committee. 14.155 Section 14.155 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... deposits and fees required by this section are to be paid by money order, bank draft, or certified check...

  17. 21 CFR 14.40 - Establishment and renewal of advisory committees.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Establishment and renewal of advisory committees. 14.40 Section 14.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., color, national origin, religion, age, or sex. (3) It is constituted and utilizes procedures designed to...

  18. 21 CFR 14.20 - Notice of hearing before an advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Notice of hearing before an advisory committee. 14.20 Section 14.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an...

  19. 21 CFR 14.35 - Written submissions to an advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Written submissions to an advisory committee. 14.35 Section 14.35 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... of the written summary along with a proposed agenda outlining the topics to be covered and...

  20. 21 CFR 14.22 - Meetings of an advisory committee.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Meetings of an advisory committee. 14.22 Section... of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. (1) If any matter is added to the agenda after...

  1. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

  2. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

  3. 76 FR 21877 - Environmental Management Advisory Board

    Science.gov (United States)

    2011-04-19

    ... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of call for nominations for appointment to the Environmental Management Advisory Board. SUMMARY... Environmental Management Advisory Board. DATES: Nominations will be accepted through May 13, 2011. ADDRESSES...

  4. ITS Standards Advisory : Dynamic Message Signs (DMS)

    Science.gov (United States)

    2003-01-01

    ITS Standards Advisories provide the transportation community with information and guidance on key activities related to ITS standards, with each Advisory focusing on a single ITS application and its corresponding standards. This advisory focuses on ...

  5. A high throughput amenable Arabidopsis-P. aeruginosa system reveals a rewired regulatory module and the utility to identify potent anti-infectives.

    Directory of Open Access Journals (Sweden)

    Suresh Gopalan

    2011-01-01

    Full Text Available We previously demonstrated that in a metasystem consisting of Arabidopsis seedlings growing in liquid medium (in 96 well plates even microbes considered to be innocuous such as laboratory strains of E. coli and B. subtilis can cause potent damage to the host. We further posited that such environment-induced adaptations are brought about by 'system status changes' (rewiring of pre-existing cellular signaling networks and components of the host and the microbe, and that prolongation of such a situation could lead to the emergence of pathogenic states in real-life. Here, using this infection model, we show that the master regulator GacA of the human opportunistic pathogen P. aeruginosa (strain PA14 is dispensable for pathogenesis, as evidenced by three independent read-outs. The gene expression profile of the host after infection with wild type PA14 or the gacA mutant are also identical. GacA normally acts upstream of the quorum sensing regulatory circuit (that includes the regulator LasR that controls a subset of virulence factors. Double mutants in gacA and lasR behave similar to the lasR mutant, as seen by abrogation of a characteristic cell type specific host cell damage caused by PA14 or the gacA mutant. This indicates that a previously unrecognized regulatory mechanism is operative under these conditions upstream of LasR. In addition, the detrimental effect of PA14 on Arabidopsis seedlings is resistant to high concentrations of the aminoglycoside antibiotic gentamicin. These data suggest that the Arabidopsis seedling infection system could be used to identify anti-infectives with potentially novel modes of action.

  6. A high throughput amenable Arabidopsis-P. aeruginosa system reveals a rewired regulatory module and the utility to identify potent anti-infectives.

    Science.gov (United States)

    Gopalan, Suresh; Ausubel, Frederick M

    2011-01-21

    We previously demonstrated that in a metasystem consisting of Arabidopsis seedlings growing in liquid medium (in 96 well plates) even microbes considered to be innocuous such as laboratory strains of E. coli and B. subtilis can cause potent damage to the host. We further posited that such environment-induced adaptations are brought about by 'system status changes' (rewiring of pre-existing cellular signaling networks and components) of the host and the microbe, and that prolongation of such a situation could lead to the emergence of pathogenic states in real-life. Here, using this infection model, we show that the master regulator GacA of the human opportunistic pathogen P. aeruginosa (strain PA14) is dispensable for pathogenesis, as evidenced by three independent read-outs. The gene expression profile of the host after infection with wild type PA14 or the gacA mutant are also identical. GacA normally acts upstream of the quorum sensing regulatory circuit (that includes the regulator LasR) that controls a subset of virulence factors. Double mutants in gacA and lasR behave similar to the lasR mutant, as seen by abrogation of a characteristic cell type specific host cell damage caused by PA14 or the gacA mutant. This indicates that a previously unrecognized regulatory mechanism is operative under these conditions upstream of LasR. In addition, the detrimental effect of PA14 on Arabidopsis seedlings is resistant to high concentrations of the aminoglycoside antibiotic gentamicin. These data suggest that the Arabidopsis seedling infection system could be used to identify anti-infectives with potentially novel modes of action.

  7. New Antimicrobial Approaches: Reuse of Old Drugs.

    Science.gov (United States)

    Savoia, Dianella

    2016-01-01

    The global situation of antibiotic resistance and the reduction of investments in antibiotics research by the pharmaceutical industry suggest the need for specific cost-effective approaches in order to identify drugs for the therapy of many microbial infections. Among the viable alternative anti-infective compounds, drug repurposing, i.e. to find new uses for previously approved medicines, revealed some encouraging in vitro and in vivo results. In this article the reader has a panoramic view of the updated references on the strategies encountered during the repositioning process. New findings are reported about the anti-microbial efficacy of antipsychotic, cardiovascular, anti-inflammatory and anti-neoplastic drugs. This approach may enhance the portfolio of pharmaceutical companies reducing the need for pharmacokinetic and toxicity studies; the development of new uses of old drugs for different infectious diseases, leading to better health for patients, also in poor, tropical countries, appears to be having better results.

  8. Ash cloud aviation advisories

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, T.J.; Ellis, J.S. [Lawrence Livermore National Lab., CA (United States); Schalk, W.W.; Nasstrom, J.S. [EG and G, Inc., Pleasanton, CA (United States)

    1992-06-25

    During the recent (12--22 June 1991) Mount Pinatubo volcano eruptions, the US Air Force Global Weather Central (AFGWC) requested assistance of the US Department of Energy`s Atmospheric Release Advisory Capability (ARAC) in creating volcanic ash cloud aviation advisories for the region of the Philippine Islands. Through application of its three-dimensional material transport and diffusion models using AFGWC meteorological analysis and forecast wind fields ARAC developed extensive analysis and 12-hourly forecast ash cloud position advisories extending to 48 hours for a period of five days. The advisories consisted of ``relative`` ash cloud concentrations in ten layers (surface-5,000 feet, 5,000--10,000 feet and every 10,000 feet to 90,000 feet). The ash was represented as a log-normal size distribution of 10--200 {mu}m diameter solid particles. Size-dependent ``ashfall`` was simulated over time as the eruption clouds dispersed. Except for an internal experimental attempt to model one of the Mount Redoubt, Alaska, eruptions (12/89), ARAC had no prior experience in modeling volcanic eruption ash hazards. For the cataclysmic eruption of 15--16 June, the complex three-dimensional atmospheric structure of the region produced dramatically divergent ash cloud patterns. The large eruptions (> 7--10 km) produced ash plume clouds with strong westward transport over the South China Sea, Southeast Asia, India and beyond. The low-level eruptions (< 7 km) and quasi-steady-state venting produced a plume which generally dispersed to the north and east throughout the support period. Modeling the sequence of eruptions presented a unique challenge. Although the initial approach proved viable, further refinement is necessary and possible. A distinct need exists to quantify eruptions consistently such that ``relative`` ash concentrations relate to specific aviation hazard categories.

  9. Atmospheric release advisory capability

    International Nuclear Information System (INIS)

    Sullivan, T.J.

    1981-01-01

    The ARAC system (Atmospheric Release Advisory Capability) is described. The system is a collection of people, computers, computer models, topographic data and meteorological input data that together permits a calculation of, in a quasi-predictive sense, where effluent from an accident will migrate through the atmosphere, where it will be deposited on the ground, and what instantaneous and integrated dose an exposed individual would receive

  10. Mentorship through advisory colleges.

    Science.gov (United States)

    Murr, Andrew H; Miller, Carol; Papadakis, Maxine

    2002-11-01

    Medical students face pressures ranging from the need to create a social network to learning vast amounts of scientific material. Students often feel isolated in this system and lack mentorship. In order to counteract feelings of bureaucratic anonymity and isolation, the University of California San Francisco has created an advisory college to foster the professional and personal growth and well being of students. UCSF has developed a formal structure to advise medical students. A selection committee, chaired by the associate dean of student affairs, appointed five faculty mentors to head advisory colleges. These five colleges serve as the advising and well-being infrastructure for the students. Mentors were chosen from a balanced range of clinical disciplines, both primary and specialty. The disciplines are obstetrics-gynecology, otolaryngology/head and neck surgery, medicine, pediatrics, and psychiatry. The mentors have demonstrated excellence in advising and counseling of students. Mentors meet individually at the beginning of the academic year with incoming first-year and second-year students. They then have bimonthly meetings with eight to ten students within each college throughout the academic year. Curricula for these group sessions include well-being discussions and coping techniques, sessions on the hidden and informal curriculum of professionalism, and discussions on career choices and strategies. For third-year students, advisory college meetings are scheduled during intersessions, which are weeklong courses that occur between the eight-week clerkship blocks. Mentors are available throughout the year to meet with students on an as-needed basis, and advisory colleges may hold group social activities. The dean's office supports each mentor with 20% salary and provides administrative support for the group college activities. Historically, UCSF students feel they receive an excellent education and appropriate job opportunities, but they do not feel they

  11. 75 FR 22757 - Federal Advisory Committee; Army Education Advisory Committee; Charter Renewal

    Science.gov (United States)

    2010-04-30

    ..., school curriculums, educational philosophy and objectives, program effectiveness, facilities, staff and... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Army Education Advisory... Defense gives notice that it is renewing the charter for the Army Education Advisory Committee (hereafter...

  12. 77 FR 64335 - Notification of a Public Teleconference of the Science Advisory Board; Perchlorate Advisory Panel

    Science.gov (United States)

    2012-10-19

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL--9743-2] Notification of a Public Teleconference of the Science Advisory Board; Perchlorate Advisory Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office...

  13. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

  14. Joint Advisory Appeals Board

    CERN Multimedia

    2013-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a former member of the personnel, a beneficiary of the CERN Pension Fund, against the calculation of his pension in the framework of the Progressive Retirement Programme.   The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be available from 26 July to 11 August 2013 at the following link. HR Department Head Office

  15. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Luc Vos with regard to advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 14 to 28 June 2002. Human Resources Division Tel. 74128

  16. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel against the decision to grant him only a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main building (bldg. 500) from 1 September to 14 September 2008. Human Resources Department (73911)

  17. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Poul Frandsen concerning his assimilation into the new career structure. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 13 to 24 January 2003. Human Resources Division Tel. 74128

  18. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Personnel Division

    1999-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Joào Bento with regard to residential category. As the appellant has not objected, the recommendations of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article RÊVIÊ1.20 of the Staff Regulations.The relevant documents will therefore be posted on the notice boards of the Administration Building (N¡ 60) from 29 October to 12 November 1999.Personnel DivisionTel. 74128

  19. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2006-01-01

    The Joint Advisory Appeals Board was convened to examine an appeal lodged by a member of the personnel with regard to advancement. The person concerned has requested that the report of the Board and the final decision of the Director-General be brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (No. 60) from 24 March to 10 April 2006. Human Resources Department Tel. 74128

  20. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2007-01-01

    The Joint Advisory Appeals Board was convened to examine an internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has requested that the report of the Board and the final decision of the Director-General be brought to the notice of the members of the personnel, in accordance with Article R VI 1.18 of the Staff Regulations. The relevant documents will therefore be posted on the notice board of the Main building (Bldg. 60) from 24 September to 7 October 2007. Human Resources Department

  1. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2001-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Olivier Francis Martin with regard to indefinite contract. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 8 to 25 June 2001.

  2. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Jack Blanchard with regard to 'non recognition of specific functions'. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 12th to 26th April 2002. Human Resources Division Tel. 74128

  3. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mrs Judith Igo-Kemenes concerning the application of procedures foreseen by Administrative Circular N§ 26 (Rev. 3). As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 6 to 20 June 2003. Human Resources Division Tel. 74128

  4. Joint Advisory Appeals Board

    CERN Multimedia

    2004-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mrs Maria DIMOU with regard to a periodic one-step increase. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 30 April to 14 May 2004. Human Resources Department Tel. 74128

  5. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2001-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Joël Lahaye with regard to non-resident allowance. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 18 May to 1st June 2001.

  6. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel with regard to the decision not to award him a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main building (Bldg. 500) from 17 March to 30 March 2008. Human Resources Department Tel. 73911

  7. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Bertrand Nicquevert with regard to the non-resident allowance. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 29 November to 13 December 2002. Human Resources Division Tel. 74128

  8. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Antonio Millich with regard to advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 27 September to 11 October 2002. Human Resources Division Tel. 74128

  9. Joint Advisory Appeals Board

    CERN Multimedia

    Human Resources Department

    2005-01-01

    The Joint Advisory Appeals Board was convened to examine an appeal lodged by a member of the personnel with regard to a periodic one-step increase. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 1 to 15 April 2005. Human Resources Department Tel. 74128

  10. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel against the decision to grant him only a periodic one-step advancement for the 2006 reference year. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the attention of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main Building (Bldg. 500) from 1 September to 14 September 2008. Human Resources Department (73911)

  11. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Gert Jan Bossen with regard to dependent child allowance. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 1st to 15 March 2002. Human Resources Division Tel. 74128

  12. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board has examined the internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel. In application of Article R VI 1.18 of the Staff Regulations, these documents will therefore be posted on the notice board of the Main Building (Bldg. 500) from 26 May to 6 June 2008. Human Resources Department (73911)

  13. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2002-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Serge Peraire with regard to exceptional advancement. As the appellant has not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 17 to 31 May 2002. Human Resources Division Tel. 74128

  14. Joint Advisory Appeals Board

    CERN Multimedia

    HR Department

    2008-01-01

    The Joint Advisory Appeals Board was convened to examine an internal appeal lodged by a member of the personnel with regard to the decision not to grant him an indefinite contract. The person concerned has not objected to the report of the Board and the final decision of the Director-General being brought to the notice of the members of the personnel, in accordance with Article R VI 1.18 of the Staff Regulations. These documents will therefore be posted on the notice board of the Main Building (Bldg. 60) from 21 January to 3 February 2008. Human Resources Department (73911)

  15. Joint Advisory Appeals Board

    CERN Multimedia

    2003-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Aloïs Girardoz with regard to classification and advancement. As the appellant has not objected, the Board's report and the Director-General's decision will be brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 15 to 29 August 2003. Human Resources Division Tel. 74128

  16. KZHU Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  17. KZOA Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  18. KZJX Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  19. KZBW Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  20. KZFW Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  1. KZSE Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  2. KZME Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  3. KZDV Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  4. KZNY Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  5. KZDC Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  6. KZAU Center Weather Advisory (CWA)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CWA is an aviation weather warning for conditions meeting or approaching national in-flight advisory (AIRMET, SIGMET or SIGMET for convection) criteria. CWAs are...

  7. Crash course in readers' advisory

    CERN Document Server

    Orr, Cynthia

    2014-01-01

    One of the key services librarians provide is helping readers find books they'll enjoy. This ""crash course"" will furnish you with the basic, practical information you need to excel at readers' advisory (RA) for adults and teens.

  8. 76 FR 29752 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Science.gov (United States)

    2011-05-23

    ... Management, for the purpose of identifying leading business practices that have the potential to improve...'s Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY: Office...: The President's Management Advisory Board, a Federal Advisory Committee established in accordance with...

  9. 76 FR 52016 - NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-08-19

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...

  10. 77 FR 43064 - Meeting; Technology Advisory Committee

    Science.gov (United States)

    2012-07-23

    ... customer fund segregation laws, and making false statements in financial statements filed with the... COMMODITY FUTURES TRADING COMMISSION Meeting; Technology Advisory Committee AGENCY: Commodity Futures Trading Commission (CFTC). ACTION: Notice of emergency meeting of technology advisory committee...

  11. Advisory and autonomous cooperative driving systems

    NARCIS (Netherlands)

    Broek, T.H.A. van den; Ploeg, J.; Netten, B.D.

    2011-01-01

    In this paper, the traffic efficiency of an advisory cooperative driving system, Advisory Acceleration Control is examined and compared to the efficiency of an autonomous cooperative driving system, Cooperative Adaptive Cruise Control. The algorithms and implementation thereof are explained. The

  12. JOINT ADVISORY APPEALS BOARD

    CERN Multimedia

    Human Resources Division

    2001-01-01

    The Joint Advisory Appeals Board was convened to examine the appeal lodged by Mr Neil Calder, Mrs Sudeshna Datta Cockerill, Mrs Andrée Fontbonne, Mrs Moniek Laurent and Mr Ulrich Liptow with regard to membership in the Pension Fund under the period with a Paid Associate contract, appeals dealt with on a collective basis. As the appellants have not objected, the report of the Board and the final decision of the Director-General are brought to the notice of the personnel in accordance with Article R VI 1.20 of the Staff Regulations. The relevant documents will therefore be posted on the notice boards of the Administration Building (N° 60) from 10 to 31 August 2001.

  13. Atmospheric Release Advisory Capability

    International Nuclear Information System (INIS)

    Dickerson, M.H.; Gudiksen, P.H.; Sullivan, T.J.

    1983-02-01

    The Atmospheric Release Advisory Capability (ARAC) project is a Department of Energy (DOE) sponsored real-time emergency response service available for use by both federal and state agencies in case of a potential or actual atmospheric release of nuclear material. The project, initiated in 1972, is currently evolving from the research and development phase to full operation. Plans are underway to expand the existing capability to continuous operation by 1984 and to establish a National ARAC Center (NARAC) by 1988. This report describes the ARAC system, its utilization during the past two years, and plans for its expansion during the next five to six years. An integral part of this expansion is due to a very important and crucial effort sponsored by the Defense Nuclear Agency to extend the ARAC service to approximately 45 Department of Defense (DOD) sites throughout the continental US over the next three years

  14. 76 FR 14980 - National Institute on Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of...

    Science.gov (United States)

    2011-03-18

    ... Alcohol Abuse and Alcoholism; National Institute on Drug Abuse; Notice of Meeting Pursuant to section 10(a... meeting of the National Advisory Council on Alcohol Abuse and Alcoholism and the National Advisory Council on Drug Abuse. The meeting will be open to the public, with attendance limited to space available...

  15. 5 CFR 724.403 - Advisory guidelines.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

  16. 78 FR 40487 - National Infrastructure Advisory Council

    Science.gov (United States)

    2013-07-05

    ... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0033] National Infrastructure Advisory... an open Federal Advisory Committee Meeting. SUMMARY: The National Infrastructure Advisory Council..., from 1:30 p.m. to 4:30 p.m. The meeting may close early if the committee has completed its business...

  17. 77 FR 19300 - National Infrastructure Advisory Council

    Science.gov (United States)

    2012-03-30

    ... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0012] National Infrastructure Advisory... an open Federal Advisory Committee meeting. SUMMARY: The National Infrastructure Advisory Council... business. For additional information, please consult the NIAC Web site, www.dhs.gov/NIAC , or contact the...

  18. [The Editorial Advisory Committee].

    Science.gov (United States)

    Reyes, H

    1996-12-01

    Since 1970, Revista Médica de Chile applies the peer review system as a main step in the selection and improvement of the manuscripts to be published. Over 150 experts participate in this process annually, reviewing up to 5 manuscripts per year. The final decision with regards to to the acceptability of a manuscript remains a responsibility of the Editor. The reviewers are selected by the Editor and his Associates among clinical investigators, prominent subspecialits and basic scientists, according to the nature of the manuscript. Most of them work in Chile. Their names are published and their confidential work is acknowledged in a special chronicle published in the Revista once a year. A small number of these reviewers appears in every issue of the journal identified as Members of its Editorial Advisory Committee. They have been selected by the Editors among those reviewers who deal with a greater number of manuscripts and also those experienced specialists whose opinion is requested when an exceptional conflict of opinions is raised by the authors and their reviewers. After 5 to 10 years of a highly praised collaboration, the previous Committee has been changed and new names were included, starting in this issue of Revista Médica de Chile.

  19. 77 FR 19740 - Biological Sciences Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-02

    ... NATIONAL SCIENCE FOUNDATION Biological Sciences Advisory Committee; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L., 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Biological Sciences Advisory Committee ( 1110). Date and...

  20. 75 FR 29781 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2010-05-27

    ...] President's National Security Telecommunications Advisory Committee AGENCY: National Protection and Programs... Security Telecommunications Advisory Committee (NSTAC) will be meeting by teleconference; the meeting will... telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public...

  1. 78 FR 68887 - Dodd-Frank Investor Advisory Committee; Meeting

    Science.gov (United States)

    2013-11-15

    ... Investor Advisory Committee; Meeting AGENCY: Securities and Exchange Commission. ACTION: Notice of Meeting of Securities and Exchange Commission Dodd- Frank Investor Advisory Committee. SUMMARY: The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the...

  2. 75 FR 6651 - Biological and Environmental Research Advisory Committee

    Science.gov (United States)

    2010-02-10

    ... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...

  3. 78 FR 6087 - Biological and Environmental Research Advisory Committee

    Science.gov (United States)

    2013-01-29

    ... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Office of... the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee... Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and...

  4. 77 FR 4028 - Biological and Environmental Research Advisory Committee

    Science.gov (United States)

    2012-01-26

    ... DEPARTMENT OF ENERGY Biological and Environmental Research Advisory Committee AGENCY: Department... meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory.... Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown...

  5. 76 FR 19147 - Aerospace Safety Advisory Panel; Meeting.

    Science.gov (United States)

    2011-04-06

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel.... Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  6. 76 FR 62455 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-10-07

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-088)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Burch, Aerospace Safety Advisory Panel Administrative Officer, National Aeronautics and Space...

  7. 78 FR 56941 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-09-16

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 13-114] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  8. 77 FR 25502 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2012-04-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-030)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Harmony Myers, Aerospace Safety Advisory Panel Executive Director...

  9. 77 FR 38090 - Aerospace Safety Advisory Panel; Meeting.

    Science.gov (United States)

    2012-06-26

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-044] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  10. 78 FR 1265 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2013-01-08

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 13-001] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel..., Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  11. 75 FR 6407 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2010-02-09

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10- 020)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announce a forthcoming meeting of the Aerospace Safety Advisory Panel... FURTHER INFORMATION CONTACT: Ms. Kathy Dakon, Aerospace Safety Advisory Panel Executive Director, National...

  12. 75 FR 61219 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2010-10-04

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-116)] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel... Dakon, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space Administration...

  13. 77 FR 58413 - Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2012-09-20

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 12-074] Aerospace Safety Advisory Panel... Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel.... Harmony Myers, Aerospace Safety Advisory Panel Executive Director, National Aeronautics and Space...

  14. 75 FR 74026 - Biomass Research and Development Technical Advisory Committee

    Science.gov (United States)

    2010-11-30

    ... DEPARTMENT OF ENERGY Biomass Research and Development Technical Advisory Committee AGENCY.... SUMMARY: This notice announces an open meeting of the Biomass Research and Development Technical Advisory... participation. This notice announces the meeting of the Biomass Research and Development Technical Advisory...

  15. 77 FR 2700 - National Advisory Council on Minority Business Enterprise: Meeting of the National Advisory...

    Science.gov (United States)

    2012-01-19

    ... Business Enterprise: Meeting of the National Advisory Council on Minority Business Enterprise AGENCY.... SUMMARY: The National Advisory Council for Minority Business Enterprise (NACMBE) will hold its fifth... deliberate on possible recommendations. The Subcommittee topics include: (1) Definition of Minority Business...

  16. 77 FR 38065 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Science.gov (United States)

    2012-06-26

    ... for the implementation of best business practices to improve Federal Government management and... management, IT vendor performance management, Senior Executive Service (SES) leadership development and SES... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...

  17. 77 FR 12841 - The President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting

    Science.gov (United States)

    2012-03-02

    ... for the implementation of best business practices to improve Federal Government management and... performance management, Senior Executive Service (SES) leadership development and SES performance appraisal... President's Management Advisory Board (PMAB); Notification of Upcoming Public Advisory Meeting AGENCY...

  18. 77 FR 55863 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Science.gov (United States)

    2012-09-11

    ... Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics... the Applied Science Advisory Group. This Subcommittee reports to the Earth Science Subcommittee... following topics: --Applied Sciences Program Update --Earth Science Data Latency Study Preliminary Update...

  19. 76 FR 64122 - NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter

    Science.gov (United States)

    2011-10-17

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-095)] NASA Advisory Committee; Renewal of NASA's International Space Station Advisory Committee Charter AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of renewal and amendment of the Charter of the International...

  20. 76 FR 5160 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2011-01-28

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Committee on Diversity for Communications in the Digital Age (``Diversity Committee''). ADDRESSES: A copy of...

  1. 76 FR 64348 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2011-10-18

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...

  2. 77 FR 57085 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2012-09-17

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...

  3. 77 FR 6113 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2012-02-07

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...

  4. 78 FR 21354 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2013-04-10

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee''). The Committee's mission is to provide...

  5. Serving Boys through Readers' Advisory

    Science.gov (United States)

    Sullivan, Michael

    2010-01-01

    Based on more than twenty years' experience working to get boys interested in reading, the author now offers his first readers' advisory volume. With an emphasis on nonfiction and the boy-friendly categories of genre fiction, the work offers a wealth of material including: (1) Suggestions for how to booktalk one-on-one as well as in large groups;…

  6. ITER management advisory committee meeting

    International Nuclear Information System (INIS)

    Yoshikawa, M.

    2001-01-01

    The ITER Management Advisory Committee (MAC) Meeting was held on 23 February in Garching, Germany. The main topics were: the consideration of the report by the Director on the ITER EDA Status, the review of the Work Programme, the review of the Joint Fund, the review of a schedule of ITER meetings, and the arrangements for termination and wind-up of the EDA

  7. Joint Advisory Appeals Board report

    CERN Document Server

    Lalande, Amanda

    2018-01-01

    With regard to the internal appeal procedure, Article R VI 1.18 of the Staff Rules and Regulations states that unless the member of the personnel objects, (the) decision and report of the JAAB (Joint Advisory Appeals Board) shall be brought to the attention of the members of the personnel.

  8. ITER management advisory committee meeting

    International Nuclear Information System (INIS)

    Yoshikawa, M.

    2001-01-01

    The ITER Management Advisory Committee (MAC) Meeting was held in Vienna on 16 July 2001. It was the last MAC Meeting and the main topics were consideration of the report by the Director on the ITER EDA status, review of the Work Programme, review of the Joint Fund and arrangements for termination and wind-up of the EDA

  9. 77 FR 25706 - Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group

    Science.gov (United States)

    2012-05-01

    ... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... [[Page 25707

  10. Promising biocidal activity of thymol loaded chitosan silver nanoparticles (T-C@AgNPs) as anti-infective agents against perilous pathogens.

    Science.gov (United States)

    Manukumar, H M; Umesha, S; Kumar, H N Naveen

    2017-09-01

    The advent of biodegradable polymer-encapsulated drug nanoparticles has made an exciting area of drug delivery research. The present study investigated novel and simple route for synthesis of thymol loaded chitosan silver nanoparticles (T-C@AgNPs) using chitosan and thymol as reducing, capping agent respectively to understand the therapeutic efficacy. The UV-vis spectroscopy, DLS, FT-IR, SEM, EDS, XRD used for characterization and radical scavenging activity, anti-microbial and biocompatibility was taken to ascertain an efficacy of novel T-C@AgNPs. The T-C@AgNPs intense peak at 490nm indicates the formation of nanoparticles and had average particle size of 28.94nm with spherical shape, monodisperse state in water, also exhibited excellent biocompatibility of cubic shaped pure silver element containing T-C@AgNPs. The antibacterial activity was studied for gram positive and gram negative food-borne pathogens and effective inhibition at 100μgmL -1 to S. aureus, S. epidermidis, S. haemolyticus (10.08, 10.00, 11.23mm) and S. typhimurium, P. aeruginosa and S. flexneri (9.28, 9.33, 12.03mm) compared to antibiotic Streptomycin. This study revealed the efficacy against multiple food-borne pathogens and therapeutic efficacy of T-C@AgNPs offers a valuable contribution in the area of nanotechnology. This proved to be a first-class novel antimicrobial material for the first time in this study. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. 77 FR 51966 - Eastern Arizona Resource Advisory Committee

    Science.gov (United States)

    2012-08-28

    ... DEPARTMENT OF AGRICULTURE Forest Service Eastern Arizona Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Eastern Arizona Resource Advisory Committee...

  12. 75 FR 51985 - Federal Advisory Committee; Advisory Council on Dependents' Education (ACDE)

    Science.gov (United States)

    2010-08-24

    ... Advisory Council on Dependents' Education (ACDE) scheduled for September 8, 2010, is cancelled. The meeting... submit written statements to the Advisory Council on Dependents' Education about its mission and... planned meeting of the Advisory Council on Dependents' Education. All written statements shall be...

  13. 75 FR 36373 - Federal Advisory Committee; Advisory Council on Dependents' Education

    Science.gov (United States)

    2010-06-25

    ..., the Department of Defense announces that the Advisory Council on Dependents' Education will meet on... response to the stated agenda of the planned meeting of the Advisory Council on Dependents' Education. All... membership for their consideration. For the next meeting of the Advisory Council on Dependents' Education, Dr...

  14. 75 FR 9184 - Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting

    Science.gov (United States)

    2010-03-01

    ... 102-3.150, the Department of Defense announces that the Advisory Council on Dependents' Education will... Advisory Council on Dependents' Education about its mission and functions. Written statements may be... Advisory Council on Dependents' Education, Mr. Charles Toth, telephone (703) 588-3105, 4040 North Fairfax...

  15. 75 FR 33616 - Science Advisory Board Staff Office; Notification of Closed Meetings of the Science Advisory...

    Science.gov (United States)

    2010-06-14

    ... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the....gov . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400F), U.S. Environmental...

  16. 76 FR 44912 - Science Advisory Board Staff Office; Notification of Closed Meetings of the Science Advisory...

    Science.gov (United States)

    2011-07-27

    ... Closed Meetings of the Science Advisory Board's Scientific and Technological Achievement Awards Committee... Agency's (EPA), Science Advisory Board (SAB) Staff Office announces a meeting and teleconference of the[email protected] . The SAB Mailing address is: U.S. EPA Science Advisory Board (1400R), U.S. Environmental...

  17. 75 FR 9416 - Advisory Committee Information Hotline

    Science.gov (United States)

    2010-03-02

    ... Microbiology Devices Panel 3014512517 Molecular and Clinical Genetics Panel 3014510231 Neurological Devices... CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee 3014512548 NATIONAL CENTER FOR...

  18. Investigating drug repositioning opportunities in FDA drug labels through topic modeling.

    Science.gov (United States)

    Bisgin, Halil; Liu, Zhichao; Kelly, Reagan; Fang, Hong; Xu, Xiaowei; Tong, Weida

    2012-01-01

    addition, we identified two therapeutic groups of drugs (Musculo-skeletal system and Anti-infective for systemic use) where over 80% of the drugs have a potential replacement with high significance. Topic modeling can be a powerful tool for the identification of repositioning opportunities by examining the adverse event terms in FDA approved drug labels. The proposed framework not only suggests drugs that can be repurposed, but also provides insight into the safety of repositioned drugs.

  19. Aerospace Safety Advisory Panel

    Science.gov (United States)

    1999-01-01

    This report covers the activities of the Aerospace Safety Advisory Panel (ASAP) for calendar year 1998-a year of sharp contrasts and significant successes at NASA. The year opened with the announcement of large workforce cutbacks. The slip in the schedule for launching the International Space Station (ISS) created a five-month hiatus in Space Shuttle launches. This slack period ended with the successful and highly publicized launch of the STS-95 mission. As the year closed, ISS assembly began with the successful orbiting and joining of the Functional Cargo Block (FGB), Zarya, from Russia and the Unity Node from the United States. Throughout the year, the Panel maintained its scrutiny of NASA's safety processes. Of particular interest were the potential effects on safety of workforce reductions and the continued transition of functions to the Space Flight Operations Contractor. Attention was also given to the risk management plans of the Aero-Space Technology programs, including the X-33, X-34, and X-38. Overall, the Panel concluded that safety is well served for the present. The picture is not as clear for the future. Cutbacks have limited the depth of talent available. In many cases, technical specialties are 'one deep.' The extended hiring freeze has resulted in an older workforce that will inevitably suffer significant departures from retirements in the near future. The resulting 'brain drain' could represent a future safety risk unless appropriate succession planning is started expeditiously. This and other topics are covered in the section addressing workforce. The major NASA programs are also limited in their ability to plan property for the future. This is of particular concern for the Space Shuttle and ISS because these programs are scheduled to operate well into the next century. In the case of the Space Shuttle, beneficial and mandatory safety and operational upgrades are being delayed because of a lack of sufficient present funding. Likewise, the ISS has

  20. WEALTH MANAGEMENT THROUGH ROBO ADVISORY

    OpenAIRE

    Ishmeet Singh; Navjot Kaur

    2017-01-01

    Use of artificial intelligence is changing the working styles of human beings in almost every sphere. From Travel, health, education, communication and other related fields, it has now entered wealth management. A number of wealth management firms have adopted the artificial intelligence based services to the clients so that they are able to get investment advice any time as per their convenience. These services are quickly accessible, cheaper, transparent and unbiased. Since the advisory ser...

  1. Advisory group on ionising radiation

    International Nuclear Information System (INIS)

    Harrison, J.R.

    1996-01-01

    The Advisory Group on Ionising Radiation has a busy and challenging work programme. Its reports will be published in the Documents of the NRPB series. These may advise further research or could form the basis of formal NRPB advice. Covering the full spectrum of radiation issues at work, in public health and clinical medicine, and the environment, it should enhance the radiation advice available to NRPB. (author)

  2. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  3. A gelatin composite scaffold strengthened by drug-loaded halloysite nanotubes.

    Science.gov (United States)

    Ji, Lijun; Qiao, Wei; Zhang, Yuheng; Wu, Huayu; Miao, Shiyong; Cheng, Zhilin; Gong, Qianming; Liang, Ji; Zhu, Aiping

    2017-09-01

    Mechanical properties and anti-infection are two of the most concerned issues for artificial bone grafting materials. Bone regeneration porous scaffolds with sustained drug release were developed by freeze-drying the mixture of nanosized drug-loaded halloysite nanotubes (HNTs) and gelatin. The scaffolds showed porous structure and excellent biocompatibility. The mechanical properties of the obtained composite scaffolds were enhanced significantly by HNTs to >300%, comparing to those of gelatin scaffold, and match to those of natural cancellous bones. The ibuprofen-loaded HNTs incorporated in the scaffolds allowed extended drug release over 100h, comparing to 8h when directly mixed the drug into the gelatin scaffold. The biological properties of the composite scaffolds were investigated by culturing MG63 cells on them. The HNTs/gelatin scaffolds with excellent mechanical properties and sustained drug release could be a promising artificial bone grating material. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Specific Stereoisomeric Conformations Determine the Drug Potency of Cladosporin Scaffold against Malarial Parasite.

    Science.gov (United States)

    Das, Pronay; Babbar, Palak; Malhotra, Nipun; Sharma, Manmohan; Jachak, Gorakhnath R; Gonnade, Rajesh G; Shanmugam, Dhanasekaran; Harlos, Karl; Yogavel, Manickam; Sharma, Amit; Reddy, D Srinivasa

    2018-05-21

    The dependence of drug potency on diastereomeric configurations is a key facet. Using a novel general divergent synthetic route for a three-chiral centre anti-malarial natural product cladosporin, we built its complete library of stereoisomers (cladologs) and assessed their inhibitory potential using parasite-, enzyme- and structure-based assays. We show that potency is manifest via tetrahyropyran ring conformations that are housed in the ribose binding pocket of parasite lysyl tRNA synthetase (KRS). Strikingly, drug potency between top and worst enantiomers varied 500-fold, and structures of KRS-cladolog complexes reveal that alterations at C3 and C10 are detrimental to drug potency where changes at C3 are sensed by rotameric flipping of Glutamate332. Given that scores of anti-malarial and anti-infective drugs contain chiral centers, this work provides a new foundation for focusing on inhibitor stereochemistry as a facet of anti-microbial drug development.

  5. Beach Advisory and Closing Online Notification (BEACON) system

    Science.gov (United States)

    Beach Advisory and Closing Online Notification system (BEACON) is a colletion of state and local data reported to EPA about beach closings and advisories. BEACON is the public-facing query of the Program tracking, Beach Advisories, Water quality standards, and Nutrients database (PRAWN) which tracks beach closing and advisory information.

  6. 75 FR 17701 - High Energy Physics Advisory Panel

    Science.gov (United States)

    2010-04-07

    ... DEPARTMENT OF ENERGY High Energy Physics Advisory Panel AGENCY: Department of Energy, Office of... Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires... Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/ Germantown Building, 1000 Independence...

  7. 77 FR 42298 - Biomass Research and Development Technical Advisory Committee

    Science.gov (United States)

    2012-07-18

    ... Biomass Research and Development Technical Advisory Committee (Technical Advisory Committee). DATES: The... 9008(d) established the Biomass Research and Development Technical Advisory Committee and lays forth... nomination. Appointments to the Biomass Research and Development Technical Advisory Committee will be made by...

  8. ITER technical advisory committee meeting at Garching

    International Nuclear Information System (INIS)

    Fujiwara, M.

    1999-01-01

    The ITER Technical Advisory Committee meeting took place on 24-27 February at the Garching Joint Work Site. According to the discussions at the ITER meeting in Yokohama in October 1998, the Technical Advisory Committee was requested to conduct a thorough review of the document 'Options for the reduced technical objectives / reduced cost ITER'

  9. 78 FR 28594 - Advisory Committee Meeting

    Science.gov (United States)

    2013-05-15

    ... draft competitiveness report, and Ex-Im Bank economic impact policy update. Public Participation: The... EXPORT-IMPORT BANK OF THE UNITED STATES Advisory Committee Meeting ACTION: Notice of Open Meeting of the Advisory Committee of the Export- Import Bank of the United States (Ex-Im Bank). Time and...

  10. 75 FR 51026 - Environmental Management Advisory Board

    Science.gov (United States)

    2010-08-18

    ... DEPARTMENT OF ENERGY Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Advisory... EMAB is to provide the Assistant Secretary for Environmental Management (EM) with advice and...

  11. 78 FR 74174 - Humanities Panel Advisory Committee

    Science.gov (United States)

    2013-12-10

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Humanities Panel Advisory Committee AGENCY: National Endowment for the Humanities. ACTION: Notice of Charter Renewal for Humanities Panel Advisory... its implementing regulations, 41 CFR 102-3.65, the National Endowment for the Humanities (NEH) gives...

  12. 39 CFR 10.2 - Advisory service.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Advisory service. 10.2 Section 10.2 Postal Service UNITED STATES POSTAL SERVICE THE BOARD OF GOVERNORS OF THE U.S. POSTAL SERVICE RULES OF CONDUCT FOR POSTAL SERVICE GOVERNORS (ARTICLE X) § 10.2 Advisory service. (a) The General Counsel is the Ethical...

  13. 75 FR 9886 - Methane Hydrate Advisory Committee

    Science.gov (United States)

    2010-03-04

    ... DEPARTMENT OF ENERGY Methane Hydrate Advisory Committee AGENCY: Department of Energy, Office of Fossil Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Methane... the Committee: The purpose of the Methane Hydrate Advisory Committee is to provide advice on potential...

  14. 78 FR 41804 - NASA Advisory Council; Meeting.

    Science.gov (United States)

    2013-07-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (13-077)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Wednesday, July 31... ADDRESSES: NASA Headquarters, Room 9H40, Program Review Center, 300 E Street SW., Washington, DC 20456 FOR...

  15. 75 FR 4588 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-01-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice 10-011] NASA Advisory Council; Meeting... Committee of the NASA Advisory Council. This will be the first meeting of this Committee. DATES: February 11, 2010--11 a.m.-1 p.m. (EST). Meet-Me-Number: 1-877-613-3958; 2939943. ADDRESSES: NASA Headquarters, 300...

  16. 76 FR 4133 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2011-01-24

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (11-007)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 10, 2011, 8 a.m.-5 p.m., Local Time. Friday, February 11, 2011, 8 a.m.-12 p.m., Local Time. ADDRESSES: NASA...

  17. 75 FR 5629 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-02-03

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-019)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council. DATES: Thursday, February 18, 2010, 9 a.m.-5 p.m. EST; Friday, February 19, 2010, 9 a.m.-1 p.m., EST. ADDRESSES: NASA Headquarters...

  18. 77 FR 9997 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2012-02-21

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-016)] NASA Advisory Council; Meeting... Space Administration announces a meeting of the NASA Advisory Council (NAC). DATES: Thursday, March 8, 2012, 8 a.m.-5 p.m., local time and Friday, March 9, 2012, 8 a.m.-12 p.m., local time. ADDRESSES: NASA...

  19. 75 FR 59747 - NASA Advisory Council; Meeting.

    Science.gov (United States)

    2010-09-28

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-113)] NASA Advisory Council; Meeting. AGENCY: National Aeronautics and Space Administration. ACTION: Notice of meeting. SUMMARY: In accordance... Space Administration announces a meeting of the NASA Advisory Council. DATES: Wednesday, October 6, 2010...

  20. 75 FR 4875 - NASA Advisory Council; Meeting

    Science.gov (United States)

    2010-01-29

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (10-015)] NASA Advisory Council; Meeting... the NASA Advisory Council. This will be the first meeting of this Committee. DATES: February 17, 2010--10 a.m.-4 p.m. (EST). ADDRESSES: NASA Headquarters, 300 E Street, SW., Washington, DC, Room CD61. FOR...

  1. 76 FR 78252 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2011-12-16

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of Renewal. SUMMARY: Pursuant to Section 14(a)(2)(A) of the Federal... hereby given that the Nuclear Energy Advisory Committee will be renewed for a two-year period. The...

  2. 76 FR 67717 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2011-11-02

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear...: [email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory...

  3. 77 FR 26274 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2012-05-03

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee...

  4. 78 FR 70932 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2013-11-27

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy, Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee (NEAC...

  5. 78 FR 76599 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2013-12-18

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy..., General Services Administration, notice is hereby given that the Nuclear Energy Advisory Committee (NEAC... to the Department of Energy's Office of Nuclear Energy on complex science and technical issues that...

  6. 75 FR 67351 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2010-11-02

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Office of Nuclear Energy, Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear... [email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory...

  7. 75 FR 13269 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2010-03-19

    ... DEPARTMENT OF ENERGY Nuclear Energy Advisory Committee AGENCY: Department of Energy, Office of Nuclear Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Nuclear[email protected]nuclear.energy.gov . SUPPLEMENTARY INFORMATION: Background: The Nuclear Energy Advisory Committee...

  8. 78 FR 70987 - Proxy Advisory Firm Roundtable

    Science.gov (United States)

    2013-11-27

    ... Firm Roundtable AGENCY: Securities and Exchange Commission. ACTION: Notice of roundtable discussion... advisory firms. The panel will be asked to discuss topics including the current state of proxy advisory firm use by investment advisers and institutional investors and potential changes that have been...

  9. 78 FR 57174 - Advisory Committee Meeting

    Science.gov (United States)

    2013-09-17

    ... recommended for inclusion on future Joint Board examinations in actuarial mathematics, pension law and... Advisory Committee on Actuarial Examinations. DATES: The meeting will be held on October 18, 2013, from 8.... SUPPLEMENTARY INFORMATION: Notice is hereby given that the Advisory Committee on Actuarial Examinations will...

  10. 78 FR 23773 - Chemical Transportation Advisory Committee

    Science.gov (United States)

    2013-04-22

    ... of Hazardous Solid Bulk Residue b. Update on International Maritime Organization as it relates to the... Advisory Committee AGENCY: Coast Guard, DHS. ACTION: Committee Management; Notice of Federal Advisory... avoid delays in processing.) Fax: 202-493-2252. Mail: Docket Management Facility (M-30), U.S. Department...

  11. 75 FR 28542 - Superior Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ... Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to orient the new Superior Resource Advisory Committee members on their roles... following business will be conducted: Overview of the roles and responsibilities of the Superior Resource...

  12. Explor@ Advisory Agent: Tracing the Student's Trail.

    Science.gov (United States)

    Lundgren-Cayrol, Karin; Paquette, Gilbert; Miara, Alexis; Bergeron, Frederick; Rivard, Jacques; Rosca, Ioan

    This paper presents research and development of an adaptive World Wide Web-based system called Explor@ Advisory Agent, capable of tailoring advice to the individual student's needs, actions, and reactions toward pedagogical events, as well as according to diagnosis of content acquisition. Explor@ Advisory Agent consists of two sub-systems, the…

  13. Advisory Boards: Gateway to Business Engagement

    Science.gov (United States)

    Meeder, Hans; Pawlowski, Brett

    2012-01-01

    Interest has been growing in how to build or manage an effective business advisory board. Developing an advisory board is crucial to keeping CTE programs relevant and viable by engaging the support of business and industry. This article delves into how to build and manage a board, and how to re-energize boards that already exist but may be lacking.

  14. 75 FR 56146 - Arts Advisory Panel; Meetings

    Science.gov (United States)

    2010-09-15

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory... amended, notice is hereby given that four meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks Center, 1100 Pennsylvania Avenue, NW., Washington, DC 20506...

  15. 78 FR 42982 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-07-18

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meetings SUMMARY... hereby given one meeting of the Arts Advisory Panel to the National Council on the Arts will be held at...

  16. 77 FR 61643 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-10-10

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that sixteen meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  17. 78 FR 17942 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-03-25

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meetings. SUMMARY... hereby given that five meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  18. 78 FR 59978 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-09-30

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  19. 77 FR 49026 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-08-15

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  20. 78 FR 21978 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-04-12

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... is hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will...

  1. 78 FR 26399 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-05-06

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meeting. SUMMARY... hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  2. 77 FR 13154 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-03-05

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice--meeting. Pursuant to... given that a meeting of the Arts Advisory Panel to the National Council on the Arts will be held by...

  3. 77 FR 67836 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-11-14

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meeting. SUMMARY... hereby given that fifteen meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  4. 78 FR 5213 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-01-24

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  5. 77 FR 75672 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-12-21

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meeting. SUMMARY... hereby given that seven meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  6. 77 FR 41808 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-07-16

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that two meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  7. 78 FR 68099 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-11-13

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meeting. SUMMARY... hereby given that twenty- one meetings of the Arts Advisory Panel to the National Council on the Arts...

  8. 78 FR 50451 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-08-19

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of Meetings. SUMMARY... hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  9. 77 FR 56875 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-09-14

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that two meetings of the Arts Advisory Panel to the National Council on the Arts will be...

  10. 77 FR 13367 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-03-06

    ... NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and Humanities. ACTION: Notice of meeting. SUMMARY... hereby given that a meeting of the Arts Advisory Panel to the National Council on the Arts will be held...

  11. A drug's life: the pathway to drug approval.

    Science.gov (United States)

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  12. 76 FR 52642 - Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group

    Science.gov (United States)

    2011-08-23

    ... DEPARTMENT OF DEFENSE Notice of Advisory Committee Closed Meeting; U.S. Strategic Command Strategic Advisory Group AGENCY: Department of Defense. ACTION: Notice of Advisory Committee closed meeting.... Strategic Command Strategic Advisory Group. DATES: November 1, 2011, from 8 a.m. to 5 p.m. and November 2...

  13. 76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-08-18

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  14. 76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-12-29

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

  15. 75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2010-03-24

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...

  16. 77 FR 22581 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-04-16

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001...

  17. 77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-08-30

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health... Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-89550, (301...

  18. 75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2010-07-20

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS...

  19. 77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2012-12-05

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  20. 78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2013-07-26

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... on Drug Abuse. Date: September 4, 2013. Closed: 8:30 AM to 10:30 AM. Agenda: To review and evaluate... program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center...

  1. 77 FR 17475 - Notification of Public Teleconferences of the Science Advisory Board; Environmental Economics...

    Science.gov (United States)

    2012-03-26

    ... Advisory Board; Environmental Economics Advisory Committee AGENCY: Environmental Protection Agency (EPA... Office announces public teleconferences of the SAB Environmental Economics Advisory Committee to conduct... Economics Advisory Committee (EEAC) will hold a public teleconferences to review the EPA draft report...

  2. 77 FR 45604 - Notification of Two Public Teleconferences of the Science Advisory Board; Environmental Economics...

    Science.gov (United States)

    2012-08-01

    ... Science Advisory Board; Environmental Economics Advisory Committee AGENCY: Environmental Protection Agency...) Staff Office announces two public teleconferences of the SAB Environmental Economics Advisory Committee...., notice is hereby given that the SAB Environmental Economics Advisory Committee (EEAC) will hold public...

  3. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-03-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  4. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

  5. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  6. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  7. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

  8. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  9. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  10. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  11. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-07-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  12. Drug Facts

    Medline Plus

    Full Text Available ... Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use and Other People Drug Use and Families Drug Use and Kids Drug Use and Unborn ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, ... Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug Use and Kids ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... People Drug Use and Families Drug Use and Kids Drug Use and Unborn Children Drug Use and ... Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used ...

  15. ITER technical advisory committee meeting

    International Nuclear Information System (INIS)

    Fujiwara, M.

    1999-01-01

    The ITER Technical Advisory Committee (TAC) meeting took place on December 20-22, 1999 at the Naka Joint Work Site. The objective of this meeting was to review the document 'Technical Basis for ITER-FEAT Outline Design (ODR)' issued by the Director on December 10. It was also aimed at providing the ITER Meeting scheduled for January 19-20, 2000 in Tokyo with a technical assessment of ODR and recommendations for the optimization of the anticipated plasma performance and engineering design, based on the guidelines approved by the Council in June 1998 and recommendations of the last TAC meeting

  16. NEW ASPECTS OF ANTI-INFECTION IMMUNITY

    Directory of Open Access Journals (Sweden)

    E. P. Kisseleva

    2011-01-01

    Full Text Available Abstract. Four types of adaptive immune response which are regulated by different T-cell populations, namely Th1, Th2, Th17 and T regs have been described. At the first time classification is based on the difference in transcription factors but not due to diversity of cytokines produced. Each population of T-lymphocytes possesses a set of unique transcription factors and directions of cell signaling. Each type of immune responses plays a key role in the protection against certain types of pathogens. The Th1-response is important against intracellular bacteria and fungi, the Th17 — against extracellular, the Th2 — against yeasts and protozoa. T-regulatory cells control all types of immune responses. Diversity of immune response mechanisms occurs due to involvement of different effector cells. The Th1-type of response is connected with macrophage activation, Th2-cells cooperate with B-lymphocytes as well as attract eosinophils and mast cells. Th17 lymphocytes stimulate neutrophils and epithelial cells. T-cell differentiation is directed by the cytokines produced by innate immune cells. Phagocytes recognize molecular patterns at the surface of pathogens via pattern-recognition receptors (PRR, become activated and synthesize cytokines. Pathogen plays important role in this process while instructing dendritic cells. Pathogen dials a special code from a number of phagocyte surface receptors, which is named as «combinatory» recognition. Phagocytes possess several different types of activation and synthesize different cytokines that direct T-lymphocytes to a certain type of differentiation.

  17. Pesticide Advisory Committees and Regulatory Partners

    Science.gov (United States)

    This site will provide all stakeholders, including the general public, with access to information about meetings of advisory committees, and how we work with state, territory, and tribal government partners.

  18. ITER management advisory committee meeting in NAKA

    International Nuclear Information System (INIS)

    Yoshikawa, M.

    1999-01-01

    The ITER Management Advisory Committee (MAC) Meeting was held on 17 December 1999 in Naka, Japan. The main topics were the ITER EDA Status, Task Status Summary and Work Program and a schedule of ITER meetings

  19. 75 FR 61454 - Electricity Advisory Committee

    Science.gov (United States)

    2010-10-05

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee AGENCY: Department of Energy, Office of.... FOR FURTHER INFORMATION CONTACT: David Meyer, Designated Federal Officer, Office of Electricity... following electronic file formats are acceptable: Microsoft Word (.doc), Corel Word Perfect (.wpd), Adobe...

  20. 78 FR 54680 - NASA Federal Advisory Committees

    Science.gov (United States)

    2013-09-05

    ... Committee Management Division, Office of International and Interagency Relations, NASA Headquarters... AGENCY: National Aeronautics and Space Administration. ACTION: Annual Invitation for Public Nominations... invitation for public nominations for service on NASA Federal advisory committees. U.S. citizens may nominate...

  1. Chemical Emergency Preparedness and Prevention Advisory: Ammonia

    Science.gov (United States)

    This advisory recommends ways Local Emergency Planning Committees (LEPCs) and chemical facilities can minimize risks from this extremely hazardous substance, especially when present in excess of its 500 pounds threshold planning quantity.

  2. 76 FR 67715 - Science Advisory Board

    Science.gov (United States)

    2011-11-02

    ... Administration (NOAA) science programs are of the highest quality and provide optimal support to resource... Advisory Board in Reviewing NOAA's Research and Development Portfolio-Presentation and Discussion; (6) NOAA...

  3. 75 FR 60145 - PNT Advisory Board; Meeting

    Science.gov (United States)

    2010-09-29

    ... Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space....m. ADDRESSES: Omni Shoreham Hotel, 2500 Calvert Street, NW. (at Connecticut Ave.), Hampton Ballroom...

  4. Right Whale Sightings Advisory System (RWSAS)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Right Whale Sighting Advisory System (RWSAS) is a NOAA Fisheries program which was designed to reduce collisions between ships and the critically endangered...

  5. 76 FR 29722 - Elko Resource Advisory Committee

    Science.gov (United States)

    2011-05-23

    ... (Pub. L. 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The...- Determination Act; (2) Review roles of RAC committee members and Committee Chairman; (3) Overview of project...

  6. 75 FR 28543 - GMUG Resource Advisory Committee

    Science.gov (United States)

    2010-05-21

    ...) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to gather the... about the roles of members, support of the committee and other pertinent information, elect a...

  7. 77 FR 16894 - Financial Research Advisory Committee

    Science.gov (United States)

    2012-03-22

    ... reported and collected; --Performing applied research and essential long-term research; --Developing tools... economics, financial institutions and markets, statistical analysis, financial markets analysis... is essential to the effective operation of the Committee. Application for Advisory Committee...

  8. Re-Inventing Infectious Disease: Antibiotic Resistance and Drug Development at the Bayer Company 1945-80.

    Science.gov (United States)

    Gradmann, Christoph

    2016-04-01

    This paper analyses how research on antibiotic resistance has been a driving force in the development of new antibiotics. Drug resistance, while being a problem for physicians and patients, offers attractive perspectives for those who research and develop new medicines. It imposes limits on the usability of older medicines and simultaneously modifies pathologies in a way that opens markets for new treatments. Studying resistance can thus be an important part of developing and marketing antibiotics. The chosen example is that of the German pharmaceutical company Bayer. Before World War Two, Bayer had pioneered the development of anti-infective chemotherapy, sulpha drugs in particular, but had missed the boat when it came to fungal antibiotics. Exacerbated by the effects of war, Bayer's world market presence, which had been considerable prior to the war, had plummeted. In this critical situation, the company opted for a development strategy that tried to capitalise on the problems created by the use of first-generation antibiotics. Part and parcel of this strategy was monitoring what can be called the structural change of infectious disease. In practice, this meant to focus on pathologies resulting from resistance and hospital infections. In addition, Bayer also focused on lifestyle pathologies such as athlete's foot. This paper will follow drug development and marketing at Bayer from 1945 to about 1980. In this period, Bayer managed to regain some of its previous standing in markets but could not escape from the overall crisis of anti-infective drug development from the 1970s on.

  9. Drug Facts

    Medline Plus

    Full Text Available ... Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used Drugs in the Past Drug Use ... Videos Information About Drugs Alcohol ...

  10. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  11. [Prescribed and dispensed in the third trimester of pregnancy drugs: What practices and risks?].

    Science.gov (United States)

    Parent, G; Mottet, N; Mairot, P; Baudier, F; Carel, D; Goguey, M; Riethmuller, D; Limat, S

    2016-09-01

    The aim of the study was to describe the prescribing of drugs to pregnant women during the third trimester of pregnancy. The retrospective analysis is interested by pregnant women from August 2009 to April 2011, living in Franche-Comté. The used data are recorded in the database of the French Health Insurance Service. Drugs prescribing were analyzed and classified according to three categories: drugs that are contraindicated, not recommended drugs and drugs that are used. This classification is based on two databases: the Summaries of Product Characteristics of Vidal 2010 and data from the National Security Agency of Medicines. The potential exposure of patients was pointed out. On 15,027 patients, 80% had a prescription. Six percent of prescriptions containing drugs not recommended and 1% drugs that contraindicated. Therapeutic classes identified are analgesics, anti-infective drugs and medicines supplementing with vitamins and minerals. Contraindicated drugs (10%) are NSAIDs, rubella vaccine, cyclins and ACE inhibitors and ARBs. Approximately 2.7% of women were potentially exposed to these drugs. Despite the recommendations of the ANSM, some drugs that are contraindicated are prescribed for pregnant women in their third trimester of pregnancy. In the absence of studies, the decision must be made on a case by case basis by assessing the risk-benefit ratio. Particular care is to bring about the drugs taken in self-medication. Information and advice are key steps to avoid incidents. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  12. Autecology Essential Oil Composition, Antibacterial, Anti Candidacies and Ethnopharmacological Survey of Ferula Gummosa L. As Anti Infection to Treat Of Vaginal Infections in Traditional Medicine of Razavi Khorasan Province (North East of Iran

    Directory of Open Access Journals (Sweden)

    Mazandarani Masoumeh

    2015-04-01

    used as natural anti-infection to treat of many infection diseases, especially in vaginal infection.

  13. The Independent Payment Advisory Board.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Falco, Frank J E; Singh, Vijay; Benyamin, Ramsin M; Hirsch, Joshua A

    2011-01-01

    The Independent Payment Advisory Board (IPAB) is a vastly powerful component of the president's health care reform law, with authority to issue recommendations to reduce the growth in Medicare spending, providing recommendations to be considered by Congress and implemented by the administration on a fast track basis. Ever since its inception, IPAB has been one of the most controversial issues of the Patient Protection and Affordable Care Act (ACA), even though the powers of IPAB are restricted and multiple sectors of health care have been protected in the law. IPAB works by recommending policies to Congress to help Medicare provide better care at a lower cost, which would include ideas on coordinating care, getting rid of waste in the system, providing incentives for best practices, and prioritizing primary care. Congress then has the power to accept or reject these recommendations. However, Congress faces extreme limitations, either to enact policies that achieve equivalent savings, or let the Secretary of Health and Human Services (HHS) follow IPAB's recommendations. IPAB has strong supporters and opponents, leading to arguments in favor of or against to the extreme of introducing legislation to repeal IPAB. The origins of IPAB are found in the ideology of the National Institute for Health and Clinical Excellence (NICE) and the impetus of exploring health care costs, even though IPAB's authority seems to be limited to Medicare only. The structure and operation of IPAB differs from Medicare and has been called the Medicare Payment Advisory Commission (MedPAC) on steroids. The board membership consists of 15 full-time members appointed by the president and confirmed by the Senate with options for recess appointments. The IPAB statute sets target growth rates for Medicare spending. The applicable percent for maximum savings appears to be 0.5% for year 2015, 1% for 2016, 1.25% for 2017, and 1.5% for 2018 and later. The IPAB Medicare proposal process involves

  14. 76 FR 40726 - Notification of Public Teleconferences of the Science Advisory Board Radiation Advisory Committee...

    Science.gov (United States)

    2011-07-11

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9435-3] Notification of Public Teleconferences of the Science... Protection Agency (EPA), Science Advisory Board Staff Office. ACTION: Notice. SUMMARY: The EPA Science... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http// www.epa...

  15. 78 FR 14299 - Notification of a Public Meeting of the Science Advisory Board Chemical Assessment Advisory...

    Science.gov (United States)

    2013-03-05

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9786-6] Notification of a Public Meeting of the Science...: Notice. SUMMARY: The Environmental Protection Agency (EPA or agency) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB Chemical Assessment Advisory Committee (CAAC) to receive a...

  16. 75 FR 70004 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-11-16

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Thursday, December 2, 2010 at...

  17. 75 FR 60458 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-09-30

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Thursday, October 14, 2010 at...

  18. 75 FR 53694 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-09-01

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Tuesday, September 21, 2010 at...

  19. 75 FR 20844 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-04-21

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Tuesday, June 15, 2010 at 2:00...

  20. 75 FR 6031 - Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital...

    Science.gov (United States)

    2010-02-05

    ... FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act; Advisory Committee on Diversity for Communications in the Digital Age AGENCY: Federal Communications Commission. ACTION: Notice of... Communications in the Digital Age (``Diversity Committee'') will hold a meeting on Wednesday, March 24, 2010 at 2...

  1. 76 FR 65736 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ...) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary... accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the...

  2. 77 FR 15110 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-14

    .../phone line to learn about possible modifications before coming to the meeting. Agenda: The committee.../tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application...

  3. 75 FR 75176 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-02

    ... Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas...

  4. 76 FR 1181 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-07

    ... or rectum) in patients for whom chemotherapy using irinotecan alone is ineffective or less effective... least two prior chemotherapy regimens; (4) NDA 21-877, tradename ARRANON (nelarabine) Injection, application submitted by GlaxoSmithKline, indicated for the treatment of patients with types of leukemia or...

  5. 76 FR 82031 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2011-12-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Risk Management Working Group Teleconference...

  6. 78 FR 53496 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  7. 78 FR 14401 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2013-03-05

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  8. 77 FR 35102 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2012-06-12

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation Advisory Committee; Public Teleconference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section...

  9. Federal Advisory Committee Act (FACA) Database-Complete-Raw

    Data.gov (United States)

    General Services Administration — The Federal Advisory Committee Act (FACA) database is used by Federal agencies to continuously manage an average of 1,000 advisory committees government-wide. This...

  10. 77 FR 76452 - Grain Inspection Advisory Committee Reestablishment

    Science.gov (United States)

    2012-12-28

    ...; Telephone (202) 205-8281; Fax (202) 690-2173; Email [email protected] . SUPPLEMENTARY INFORMATION: The... marketing of grain. The Advisory Committee serves an essential function. Information about the Advisory...

  11. 78 FR 48855 - Renewable Energy and Energy Efficiency Advisory Committee

    Science.gov (United States)

    2013-08-12

    ... Administration Renewable Energy and Energy Efficiency Advisory Committee AGENCY: International Trade... the international competitiveness of the U.S. renewable energy and energy efficiency industries. The... Renewable Energy and Energy Efficiency Advisory Committee, Attention: Ryan Mulholland, Office of Energy and...

  12. 76 FR 38608 - Sensors and Instrumentation Technical Advisory Committee;

    Science.gov (United States)

    2011-07-01

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Sensors and Instrumentation Technical Advisory Committee; Notice of Partially Closed Meeting The Sensors and Instrumentation Technical Advisory... of export controls applicable to sensors and instrumentation equipment and technology. Agenda Public...

  13. 78 FR 24239 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2013-04-24

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date... Person: Marc Rigas, Advanced Cyberinfrastructure (CISE/ ACI), National Science Foundation, 4201 Wilson...

  14. 76 FR 14436 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2011-03-16

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date... of the Director, Office of Cyberinfrastructure (OD/OCI), National Science Foundation, 4201 Wilson...

  15. 75 FR 20627 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2010-04-20

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150) Date and... Oberright, Office of the Director, Office of Cyberinfrastructure (OD/OCI), National Science Foundation, 4201...

  16. 75 FR 72843 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2010-11-26

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date.... Contact Person: Kristen Oberright, Office of the Director, Office of Cyberinfrastructure (OD/OCI...

  17. 77 FR 58871 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2012-09-24

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date..., Office of the Director, Office of Cyberinfrastructure (OD/OCI), National Science Foundation, 4201 Wilson...

  18. 77 FR 70836 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2012-11-27

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date.... Contact Person: Marc Rigas, Office of the Director, Office of Cyberinfrastructure (OD/OCI), National...

  19. 77 FR 31044 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2012-05-24

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date..., Office of Cyberinfrastructure (OD/OCI), National Science Foundation, 4201 Wilson Blvd., Suite 1145...

  20. 76 FR 69769 - Advisory Committee for Cyberinfrastructure; Notice of Meeting

    Science.gov (United States)

    2011-11-09

    ... NATIONAL SCIENCE FOUNDATION Advisory Committee for Cyberinfrastructure; Notice of Meeting In... Foundation announces the following meeting: Name: Advisory Committee for Cyberinfrastructure (25150). Date... Director, Office of Cyberinfrastructure (OD/OCI), National Science Foundation, 4201 Wilson Blvd., Suite...

  1. Beach Advisory and Closing Online Notification (BEACON) system

    Data.gov (United States)

    U.S. Environmental Protection Agency — Beach Advisory and Closing Online Notification system (BEACON) is a colletion of state and local data reported to EPA about beach closings and advisories. BEACON is...

  2. Innovative advisory services in the virtual world an empowerment perspective

    CERN Document Server

    Li, Manning

    2014-01-01

    Based on detailed analysis of applications in business and government sectors, this book discusses the current state and future trends of virtual advisory services in digital environments. Shows how to effectively design and deliver virtual advisory services.

  3. 78 FR 29145 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2013-05-17

    ... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0022] President's National Security Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... notice of a May 22, 2013, meeting of the President's National Security Telecommunications Advisory...

  4. 77 FR 75182 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2012-12-19

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Security Telecommunications Advisory Committee (NSTAC) will meet on Friday, January 11, 2013, via... related to national security and emergency preparedness telecommunications policy. Agenda: The NSTAC...

  5. 78 FR 45255 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2013-07-26

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. [[Page 45256... President's National Security Telecommunications Advisory Committee (NSTAC) will meet on Tuesday, August 20... related to national security and emergency preparedness (NS/EP) telecommunications policy. Agenda: The...

  6. 75 FR 3913 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2010-01-25

    ...] President's National Security Telecommunications Advisory Committee AGENCY: National Communications System... Telecommunications Advisory Committee (NSTAC) will be meeting by teleconference; the meeting will be open to the... implementing national security and emergency preparedness telecommunications policy. Notice of this meeting is...

  7. 78 FR 40098 - Emerging Technology and Research Advisory Committee;

    Science.gov (United States)

    2013-07-03

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting The Emerging Technology and Research Advisory Committee (ETRAC... Assistant Secretary for Export Administration on emerging technology and research activities, including...

  8. 75 FR 18482 - Environmental Technologies Trade Advisory Committee (ETTAC)

    Science.gov (United States)

    2010-04-12

    ... DEPARTMENT OF COMMERCE Environmental Technologies Trade Advisory Committee (ETTAC) AGENCY... Environmental Technologies Trade Advisory Committee (ETTAC) will hold its quarterly meeting to discuss environmental technologies trade liberalization, industry competitiveness issues, and general Committee...

  9. 75 FR 1590 - Environmental Technologies Trade Advisory Committee (ETTAC)

    Science.gov (United States)

    2010-01-12

    ... DEPARTMENT OF COMMERCE Environmental Technologies Trade Advisory Committee (ETTAC) AGENCY... Environmental Technologies Trade Advisory Committee (ETTAC) will hold its first plenary meeting of 2010 to discuss environmental technologies trade liberalization, industry competitiveness issues, and general...

  10. 75 FR 52716 - Environmental Technologies Trade Advisory Committee (ETTAC)

    Science.gov (United States)

    2010-08-27

    ... DEPARTMENT OF COMMERCE Environmental Technologies Trade Advisory Committee (ETTAC) AGENCY... Environmental Technologies Trade Advisory Committee (ETTAC) will hold its quarterly meeting to discuss environmental technologies industry competitiveness issues, the National Export Initiative, and general...

  11. 77 FR 26275 - Environmental Management Advisory Board Meeting

    Science.gov (United States)

    2012-05-03

    ...This notice announces a meeting of the Environmental Management Advisory Board (EMAB). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

  12. 75 FR 20977 - Departmental Management; Advisory Committee on Minority Farmers

    Science.gov (United States)

    2010-04-22

    ...; Advisory Committee on Minority Farmers AGENCY: USDA. ACTION: Notice: Request for Nominations. SUMMARY: The Secretary of Agriculture (Secretary) establish the Advisory Committee on Minority Farmers (Committee) on... assistance to socially disadvantaged farmers and ranchers, methods of maximizing participation of minority...

  13. 16 CFR 1018.12 - Statutory advisory committees.

    Science.gov (United States)

    2010-01-01

    ... Federal Hazardous Substances Act, as amended (Pub. L. 95-631, 92 Stat. 3747, 15 U.S.C. 1275). [46 FR 63248... MANAGEMENT Establishment of Advisory Committees § 1018.12 Statutory advisory committees. The Commission has...

  14. 78 FR 25252 - Tuolumne-Mariposa Counties Resource Advisory Committee

    Science.gov (United States)

    2013-04-30

    ...-Mariposa Counties Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Tuolumne-Mariposa Counties Resource Advisory Committee will meet on May 6, 2013, (alternate...

  15. 77 FR 26023 - President's National Security Telecommunications Advisory Committee; Correction

    Science.gov (United States)

    2012-05-02

    ... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0016] President's National Security Telecommunications Advisory Committee; Correction AGENCY: National Protection and Programs Directorate, DHS. [[Page... April 25, 2012, concerning the President's National Security Telecommunications Advisory Committee...

  16. 78 FR 53496 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  17. 77 FR 52108 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2012-08-28

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  18. 76 FR 78329 - Commercial Space Transportation Advisory Committee; Public Teleconference

    Science.gov (United States)

    2011-12-16

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation...: Notice of Commercial Space Transportation Advisory Committee Teleconference. SUMMARY: Pursuant to Section... given of a teleconference of the Commercial Space Transportation Advisory Committee (COMSTAC). The...

  19. 78 FR 53497 - Commercial Space Transportation Advisory Committee; Closed Session

    Science.gov (United States)

    2013-08-29

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Special Closed Session. SUMMARY: Pursuant to Section 10(a...), notice is hereby given of a special closed session of the Commercial Space Transportation Advisory...

  20. 78 FR 18416 - Commercial Space Transportation Advisory Committee; Open Meeting

    Science.gov (United States)

    2013-03-26

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Commercial Space Transportation... Commercial Space Transportation Advisory Committee Open Meeting. SUMMARY: Pursuant to Section 10(a)(2) of the... the Commercial Space Transportation Advisory Committee (COMSTAC). The meeting will take place on...

  1. 78 FR 55683 - National Sea Grant Advisory Board

    Science.gov (United States)

    2013-09-11

    ..., but not required. NOAA is an equal opportunity employer. This notice also sets forth the schedule and.../WhoWeAre/Leadership/NationalSeaGrantAdvisoryBoard/AdvisoryBoardUpcomingMeetings.aspx . DATES...

  2. 76 FR 44574 - Yavapai County Resource Advisory Committee

    Science.gov (United States)

    2011-07-26

    ... and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory... Act, roles of members, guidelines for Title II, and the Federal Advisory Committee Act. DATES: The...

  3. 75 FR 44757 - Yavapai County Resource Advisory Committee

    Science.gov (United States)

    2010-07-29

    ... and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory... Act, roles of members, guidelines for Title II, and the Federal Advisory Committee Act. DATES: The... Designated Federal [[Page 44758

  4. 75 FR 25199 - Medbow-Routt Resource Advisory Committee

    Science.gov (United States)

    2010-05-07

    ... Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee... Advisory Committee Overview; Roles and Responsibilities of RAC; Rules/ Operational Guides and Bylaws; Flow...

  5. 76 FR 13124 - Yavapai County Resource Advisory Committee

    Science.gov (United States)

    2011-03-10

    ... and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory... Act, roles of members, guidelines for Title II, and the Federal Advisory Committee Act. DATES: The...

  6. 77 FR 31302 - Advisory Committee on Agriculture Statistics

    Science.gov (United States)

    2012-05-25

    ... DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Advisory Committee on Agriculture Statistics AGENCY: National Agricultural Statistics Service, USDA. ACTION: Notice of Renewal of the Charter for the Advisory Committee on Agriculture Statistics. SUMMARY: The U.S. Department of...

  7. 76 FR 55693 - Critical Infrastructure Partnership Advisory Council

    Science.gov (United States)

    2011-09-08

    ... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2011-0055] Critical Infrastructure Partnership... Advisory Committee Meeting. SUMMARY: The Critical Infrastructure Partnership Advisory Council (CIPAC... meeting may adjourn early if the committee has completed its business. For additional information, please...

  8. 76 FR 32390 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2011-06-06

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee (MCSAC) Meeting. SUMMARY...

  9. 77 FR 46555 - Motor Carrier Safety Advisory Committee: Public Meeting

    Science.gov (United States)

    2012-08-03

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee: Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of meeting of Motor Carrier Safety Advisory Committee (MCSAC...

  10. 75 FR 2923 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-01-19

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...

  11. 75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-05-25

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA...

  12. 75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-11-26

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces...

  13. 75 FR 50797 - Motor Carrier Safety Advisory Committee Public Meeting

    Science.gov (United States)

    2010-08-17

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...

  14. 77 FR 20377 - Biomass Research and Development Technical Advisory Committee

    Science.gov (United States)

    2012-04-04

    ... Biomass Research and Development Technical Advisory Committee under Section 9008(d) of the Food... DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Biomass Research and Development Technical Advisory Committee AGENCY: Office of Energy Efficiency and Renewable Energy, Department...

  15. 75 FR 20817 - Information Systems Technical Advisory Committee

    Science.gov (United States)

    2010-04-21

    ... equipment and technology. Wednesday, May 5 Public Session 1. Welcome and Introduction. 2. Working Group... DEPARTMENT OF COMMERCE Bureau of Industry and Security Information Systems Technical Advisory Committee Notice of Partially Closed Meeting The Information Systems Technical Advisory Committee (ISTAC...

  16. 77 FR 64464 - Information Systems Technical Advisory Committee

    Science.gov (United States)

    2012-10-22

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security Information Systems Technical Advisory Committee Notice of Partially Closed Meeting The Information Systems Technical Advisory Committee (ISTAC... of export controls applicable to information systems equipment and technology. Wednesday, November 7...

  17. 76 FR 33700 - Agricultural Policy Advisory Committee for Trade; Renewal

    Science.gov (United States)

    2011-06-09

    ...Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary of Agriculture (Secretary), in coordination with the United States Trade Representative (USTR), has renewed the Agricultural Policy Advisory Committee for Trade (APAC).

  18. 76 FR 28210 - Eastern Arizona Counties Resource Advisory Committee

    Science.gov (United States)

    2011-05-16

    ... DEPARTMENT OF AGRICULTURE Forest Service Eastern Arizona Counties Resource Advisory Committee AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Eastern Arizona Counties will meet...: Julia Faith Rivera, RAC Program Manager, Eastern Arizona Counties Resource Advisory Committee, Apache...

  19. 77 FR 35944 - Renewal of the Global Markets Advisory Committee

    Science.gov (United States)

    2012-06-15

    ... international standards for regulating futures, swaps, options, and derivatives markets, as well as..., competitive, and financially sound futures and options markets. Meetings of the Global Markets Advisory... COMMODITY FUTURES TRADING COMMISSION Renewal of the Global Markets Advisory Committee AGENCY...

  20. Naphthalene: Drinking water health advisory

    Energy Technology Data Exchange (ETDEWEB)

    1990-03-01

    The Drinking Water Health Advisory, Office of Water, U.S. Environmental Protection Agency, has issued its report on the chemical, naphthalene. Naphthalene is used in the manufacture of phthalic and anthranilic acids and other derivatives, and in making dyes; in the manufacture of resins, celluloid, lampblack and smokeless gunpowder; and as moth repellant, insecticide, anthelmintic, vermicide, and intestinal antiseptic. The report covers the following areas: the occurrence of the chemical in the environment; its environmental fate; the chemical's absorption, distribution, metabolism, and excretion in the human body; and its health effects on humans and animals, including its mutagenicity and carcinogenicity characteristics. Also included is the quantification of its toxicological effects.