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. 76 FR 59406 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-26

    ...., Silver Spring, MD. The hotel telephone number is 301- 589-5200. Contact Person: Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm... document entitled ``Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for...

  3. 76 FR 59405 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-26

    ...., Silver Spring, MD. The hotel telephone number is 301- 589-5200. Contact Person: Minh Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm...-associated bacterial pneumonia, and the draft document entitled ``Guidance for Industry: Hospital-Acquired...

  4. 75 FR 9416 - Advisory Committee Information Hotline

    Science.gov (United States)

    2010-03-02

    ... BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee 3014512388 Blood Products Advisory... Committee 3014512391 CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Life Support Drugs Advisory Committee 3014512529 Anti-Infective Drugs Advisory Committee 3014512530 Antiviral Drugs Advisory Committee...

  5. LC-MS/MS for Therapeutic Drug Monitoring of anti-infective drugs

    NARCIS (Netherlands)

    Veringa, Anette; Sturkenboom, Marieke G. G.; Dekkers, Bart G. J.; Koster, Remco A.; Roberts, Jason A.; Peloquin, Charles A.; Touw, Daan J.; Alffenaar, Jan-Willem C.

    2016-01-01

    Therapeutic drug monitoring (TDM) is a tool used to integrate pharmacokinetic and pharmacodynamic knowledge to optimise and personalize drug therapy. TDM is of specific interest for anti-infectives: to assure adequate drug exposure and reduce adverse events, to increase patient compliance and to

  6. Causes and consequences of anti-infective drug stock-outs.

    Science.gov (United States)

    Luans, C; Cardiet, I; Rogé, P; Baslé, B; Le Corre, P; Revest, M; Michelet, C; Tattevin, P

    2014-10-01

    Anti-infective drugs stock-outs are increasingly frequent, and this is unlikely to change. There are numerous causes for this, mostly related to parameters difficult to control: i) 60 to 80% of raw material or components are produced outside of Europe (compared to 20% 30 years ago), with subsequent loss of independence for their procurement; ii) the economic crisis drives the pharmaceutical companies to stop producing drugs of limited profitability (even among important drugs); iii) the enforcement of regulatory requirements and quality control procedures result in an increasing number of drugs being blocked during production. The therapeutic class most affected by drug stock-outs is that of anti-infective drugs, especially injectable ones, and many therapeutic dead ends have recently occurred. We provide an update on this issue, and suggest 2 major actions for improvement: i) to implement a group dedicated to anticipating drug stock-outs within the anti-infective committee in each health care center, with the objectives of organizing and coordinating the response whenever a drug stock-out is deemed at risk (i.e., contingency plans, substitution, communication to prescribers); ii) a national reflection lead by scientific societies, in collaboration with government agencies, upstream of the most problematic drug stock-outs, to elaborate and disseminate consensus guidelines for the management of these stock-outs. Copyright © 2014. Published by Elsevier SAS.

  7. Multiple targeted drugs carrying biodegradable membrane barrier: anti-adhesion, hemostasis, and anti-infection.

    Science.gov (United States)

    Wang, Heran; Li, Min; Hu, Jianming; Wang, Chenhong; Xu, Shanshan; Han, Charles C

    2013-04-08

    A multiple targeted drug carrying bilayer membrane for preventing an abdominal adhesion is prepared by electrospinning. Two bioactive drugs were successfully incorporated into this bilayer membrane and can be independently released from nanofibrous scaffolds without losing structural integrity and functionality of the anti-adhesion membrane. Besides, the drug release profile could be easily adjusted by optimizing the swelling behavior of the fibrous scaffold. The inner layer of the bilayered fibrous membranes loaded with carbazochrome sodium sulfonate (CA) showed an excellent vascular hemostatic efficacy and formed little clot during in vivo experiment. The outer layer loaded with tinidazole (TI) had outstanding antibacterial effect against the anaerobe. We believe this approach could serve as a model technique to guide the design of implants with drug delivery functions.

  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. 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.

  10. 77 FR 58400 - Anti-Infective Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-09-20

    ... nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus...

  11. 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...

  12. 75 FR 81283 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2010-12-27

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee was...

  13. 76 FR 25357 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Reestablishment

    Science.gov (United States)

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Advisory Committee; Medical Imaging Drugs Advisory Committee... Administration (FDA) is announcing the ] reestablishment of the Medical Imaging Drugs Advisory Committee in the.... 101-635); and 21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical Imaging Drugs...

  14. 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...

  15. 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 ...

  16. 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

  17. 77 FR 63839 - Oncologic Drugs Advisory Committee; Cancellation

    Science.gov (United States)

    2012-10-17

    ... HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Oncologic Drugs Advisory... committee have been resolved. FOR FURTHER INFORMATION CONTACT: Caleb Briggs, Center for Drug Evaluation and...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 76 FR 62418 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-07

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... enter through Building 1. Contact Person: Paul Tran, Center for Drug Evaluation and Research, Food and...

  14. 75 FR 16151 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-31

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... phone number is 301-589- 5200. Contact Person: Paul Tran, Center for Drug Evaluation and Research (HFD...

  15. 77 FR 15110 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-14

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... enter through Building 1. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food...

  16. 78 FR 56900 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-09-16

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory..., Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD...

  17. 77 FR 17487 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-26

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver...

  18. 78 FR 37820 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Nonprescription Drugs 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: Nonprescription Drugs Advisory...

  19. Anti-infective and wound healing properties of Flabellaria paniculata ...

    African Journals Online (AJOL)

    Anti-infective and wound healing properties of Flabellaria paniculata. A Abo, JAO Olugbuyiro, SA Famakinde ... was recorded in Pseudomonas aeruginosa group on day 18. This drug is anti-infective as well as wound healing agent thus justifying the local uses of the plant for the treatment of skin diseases and sores.

  20. 76 FR 14027 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-15

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... liver disease who are previously untreated or who have failed previous therapy. Compensated liver...

  1. 76 FR 14026 - Antiviral Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-03-15

    ...] Antiviral Drugs 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: Antiviral Drugs Advisory... who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage...

  2. 78 FR 37551 - Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory...

    Science.gov (United States)

    2013-06-21

    ..., Advisory Committee Oversight and Management Staff, Food and Drug Administration, White Oak Bldg. 32, 10903... Anti-Infective Drugs. Research, Food and Drug Administration, White Oak Bldg 31, 10903 New Hampshire... Drug Evaluation and Pulmonary Allergy Drugs. Research, Food and Drug Administration, White Oak Bldg 31...

  3. 76 FR 45578 - Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs...

    Science.gov (United States)

    2011-07-29

    ...] Request for Nominations for Members on a Public Advisory Committee; Medical Imaging Drugs Advisory... Administration (FDA) is requesting nominations for 12 members to serve on the Medical Imaging Drugs Advisory... final rule adding the Medical Imaging Drugs Advisory Committee to the list of FDA standing advisory...

  4. 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

  5. 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...

  6. 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...

  7. 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...

  8. HT-SPOTi: A Rapid Drug Susceptibility Test (DST) to Evaluate Antibiotic Resistance Profiles and Novel Chemicals for Anti-Infective Drug Discovery.

    Science.gov (United States)

    Danquah, Cynthia A; Maitra, Arundhati; Gibbons, Simon; Faull, Jane; Bhakta, Sanjib

    2016-02-08

    Antibiotic resistance is one of the major threats to global health and well-being. The past decade has seen an alarming rise in the evolution and spread of drug-resistant strains of pathogenic microbes. The emergence of extensively drug resistant (XDR) strains of Mycobacterium tuberculosis and antimicrobial resistance among the ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Enterobacter species) as well as fungal pathogens (such as certain species of Candida, Aspergillus, Cryptococcus, and Trichophyton) poses a significant 21st century scientific challenge. With an extremely limited arsenal of efficacious antibiotics, techniques that can (a) identify novel antimicrobials and (b) detect antimicrobial resistance are becoming increasingly important. In this article, we illustrate the HT-SPOTi, an assay that is principally based on the growth of an organism on agar medium containing a range of different concentrations of drugs or inhibitors. The simple methodology makes this assay ideal for evaluating novel antimicrobial compounds as well as profiling an organism's antibiotic resistance profile. Copyright © 2016 John Wiley & Sons, Inc.

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Science.gov (United States)

    2010-06-25

    ... Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ] General Function... and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk...

  4. 75 FR 13559 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-03-22

    ... growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is...: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  5. 77 FR 6804 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

    Science.gov (United States)

    2012-02-09

    ...] 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.... If the number of registrants requesting to speak is greater than can be reasonably accommodated...

  6. 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...

  7. 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...

  8. 78 FR 13348 - Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Science Board to the Food and Drug Administration Advisory... Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and... that a meeting of the Science Board to the Food and Drug Administration would be held on February 27...

  9. 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...

  10. 78 FR 27405 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

  11. 78 FR 29142 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001... Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

  12. 75 FR 2875 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ... analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a...: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and...

  13. 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...

  14. 77 FR 17078 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-23

    ..., Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver... visitors to the White Oak Campus must enter through Building 1. Contact Person: Minh Doan, Center for Drug... Corporation, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization...

  15. 77 FR 52743 - Nonprescription Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-08-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... trade name OXYTROL FOR WOMEN). The proposed OTC use is ``treats overactive bladder in women.'' The data... 26, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m...

  16. 75 FR 30045 - Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-05-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... women with metastatic breast cancer known as HER2-negative breast cancer, in combination with the... contact person on or before July 6, 2010. Oral presentations from the public will be scheduled between...

  17. 75 FR 59732 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-28

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver... disease (GERD) in patients less than 1 year of age, performed in response to a Pediatric Written Request... Pediatric Research Equity Act commitment (Prilosec, omeprazole by AstraZeneca LP). The pathophysiology...

  18. OxyContin: Prescription Drug Abuse. CSAT Advisory.

    Science.gov (United States)

    Substance Abuse and Mental Health Services Administration (DHHS/PHS), Rockville, MD. Center for Substance Abuse Treatment.

    Recently, the media have issued numerous reports about the apparent increase in OxyContin abuse and addiction. OxyContin has been heralded as a miracle drug that allows patients with chronic pain to resume a normal life. It has also been called pharmaceutical heroin and is thought to have been responsible for a number of deaths and robberies in…

  19. 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,...

  20. 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.

  1. Changes in antipsychotic use among patients with severe mental illness after a Food and Drug Administration advisory.

    Science.gov (United States)

    Dusetzina, Stacie B; Busch, Alisa B; Conti, Rena M; Donohue, Julie M; Alexander, G Caleb; Huskamp, Haiden A

    2012-12-01

    A 2003 Food and Drug Administration advisory warned of increased hyperlipidemia and diabetes risk for patients taking second-generation antipsychotics (SGAs). After the advisory, a professional society consensus statement provided treatment recommendations and stratified SGAs into high, intermediate, and low metabolic risk. We examine subsequent changes in incident and prevalent SGA use among individuals with severe mental illness. We created a retrospective cohort using Florida Medicaid's claims from 2001 to 2006. We included non-Medicare eligible adults with bipolar disorder or schizophrenia who filled an SGA prescription. We assessed changes in overall and agent-specific use, discontinuations, interruptions, and therapeutic alternative use among prevalent users and agent-specific use among incident users. Pre-advisory utilization was compared with utilization initially after the advisory and two subsequent periods. Among prevalent users, overall SGA use decreased slightly, and no increases in treatment interruptions or discontinuations were observed after the advisory and consensus statement publication. Compared with the pre-advisory period, in the months immediately after the advisory, the use of the highest metabolic-risk agent, olanzapine, decreased by 34% among prevalent users with bipolar disorder (adjusted risk ratio [aRR] = 0.66, 95%CI = 0.59-0.74) and 26% among prevalent users with schizophrenia (aRR = 0.74, 95%CI = 0.72-0.76). A greater decrease was estimated among incident users with bipolar disorder (aRR = 0.37, 95%CI = 0.29-0.47) and schizophrenia (aRR = 0.42, 95%CI = 0.35-0.51) during this period. During each subsequent post-advisory period, olanzapine use continued to decrease whereas quetiapine, ziprasidone, and aripiprazole use increased. The metabolic risk advisory and the published consensus statement were associated with a selective reduction in olanzapine use without evidence of treatment disruptions among

  2. Marine peptides and their anti-infective activities.

    Science.gov (United States)

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

    2015-01-16

    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.

  3. 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.

  4. 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.

  5. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Science.gov (United States)

    2013-11-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is announcing the termination of the Veterinary Medicine Advisory...

  6. 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.

  7. Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

    Science.gov (United States)

    Mckie, Janay; Qureshi, Sheeraz; Iatridis, James; Egorova, Natalia; Cho, Samuel; Hecht, Andrew

    2014-06-01

    Study Design Retrospective cross-sectional study of spinal procedures from 2002 to 2010 using the Nationwide Inpatient Sample database. Objective To determine the patterns of bone morphogenetic protein (BMP) usage in fusion surgery before and after the U.S. Food and Drug Administration (FDA) 2008 advisory for the anterior cervical spine to understand how advisories affect U.S. physician practices. Methods Procedures were identified through International Classification of Diseases, Ninth Revision procedure codes and were plotted over time based on fusion procedure type, site, and area of fusion. U.S. national trends were approximated by polynomial regression analysis. Results The majority of the data trends of BMP usage reflect a second-order polynomial model. BMP usage in anterior cervical spine fusion procedures plateaued during the fourth quarter of 2007. The most apparent change in trend was noted in BMP usage pre- and postadvisory in the analysis of anterior cervical spine fusions. BMP percentage of use decreased in this area by 5% from the time of the FDA advisory to the fourth quarter of 2010. Conclusions The decrease in BMP usage in anterior cervical spinal fusion procedures coincided with the timing of the FDA advisory. The fact that BMP continued to be used in cervical spine fusion procedures, even at lower rates, despite the advisory, may reflect the availability of new clinical information that could lessen complications (i.e., lower BMP dose, perioperative steroids, BMP containment). Furthermore, factors like the natural ceiling effect of use or demand for new technology, complications, prohibitive institutional costs, access to information, and insurance compensation may have all contributed to the BMP usage trends observed.

  8. Anti-infective potential of hot-spring bacteria

    Directory of Open Access Journals (Sweden)

    Pallavi Pednekar

    2011-01-01

    Full Text Available Aim and Background: Antibiotic resistance currently spans most of the known classes of natural and synthetic antibiotics; limiting our options for treatment of infections and demanding discovery of new classes of antibiotics. Much effort is being directed towards developing new antibiotics to overcome this problem. Success in getting novel chemical entities from microbial sources depends essentially on novelty of its habitat. The diversity of geographical location decides the type of micro-flora. In the past various terrestrial and aqueous microorganisms have provided several novel bioactive secondary metabolites of pharmaceutical importance. Hot-springs have not been as extensively exploited as other terrestrial resources. However, perseverance with such microbes augment the probability of getting novel bioactive compounds. Materials and Methods: Hot-springs soil samples were collected from Hot-springs in Maharashtra. Actinomycetes and other eubacteria were isolated from these soil samples by selective methods and purified. They were classified based on gram′s nature and morphology. Six representative morphological strains were screened for their anti-infective potential by agar well diffusion method as reported by Nathan P. et al (1974. The bioactivity of the active microbes was confirmed. Results: Seventy three strains of bacteria encompassing eight actinomycetes, and 65 eubacteria were isolated and purified. Among the actives eubacteria PPVWK106001 showed broad spectrum antibacterial activity encompassing both gram positive and gram negative bacterial test models. The extract was active against resistant bacteria such as MRSA and VREs. Activity was very specific as there was no activity against fungi even at 100 fold concentration. The active principle was extractable in butanol. Conclusions: The study showed that Hot-springs exhibit diverse bacteria and it serves as potential reservoirs for bacteria of antimicrobial importance with

  9. Gender differences in the use of anti-infective medications before and after widowhood

    DEFF Research Database (Denmark)

    Santacroce, Adriana; Wastesson, Jonas W; Höhn, Andreas

    2018-01-01

    widowhood among both men and women. Also, age-related changes in the use of anti-infective medications were similar in both genders. CONCLUSIONS: The present study shows that individuals are more likely to use anti-infective medication after being widowed than before being widowed, but this change is likely...... to be related to increasing age and it is similar in both genders....

  10. 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...

  11. 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...

  12. An anti-infective synthetic peptide with dual antimicrobial and immunomodulatory activities.

    Science.gov (United States)

    Silva, O N; de la Fuente-Núñez, C; Haney, E F; Fensterseifer, I C M; Ribeiro, S M; Porto, W F; Brown, P; Faria-Junior, C; Rezende, T M B; Moreno, S E; Lu, T K; Hancock, R E W; Franco, O L

    2016-11-02

    Antibiotic-resistant infections are predicted to kill 10 million people per year by 2050, costing the global economy $100 trillion. Therefore, there is an urgent need to develop alternative technologies. We have engineered a synthetic peptide called clavanin-MO, derived from a marine tunicate antimicrobial peptide, which exhibits potent antimicrobial and immunomodulatory properties both in vitro and in vivo. The peptide effectively killed a panel of representative bacterial strains, including multidrug-resistant hospital isolates. Antimicrobial activity of the peptide was demonstrated in animal models, reducing bacterial counts by six orders of magnitude, and contributing to infection clearance. In addition, clavanin-MO was capable of modulating innate immunity by stimulating leukocyte recruitment to the site of infection, and production of immune mediators GM-CSF, IFN-γ and MCP-1, while suppressing an excessive and potentially harmful inflammatory response by increasing synthesis of anti-inflammatory cytokines such as IL-10 and repressing the levels of pro-inflammatory cytokines IL-12 and TNF-α. Finally, treatment with the peptide protected mice against otherwise lethal infections caused by both Gram-negative and -positive drug-resistant strains. The peptide presented here directly kills bacteria and further helps resolve infections through its immune modulatory properties. Peptide anti-infective therapeutics with combined antimicrobial and immunomodulatory properties represent a new approach to treat antibiotic-resistant infections.

  13. 21 CFR 808.5 - Advisory opinions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Advisory opinions. 808.5 Section 808.5 Food and... Advisory opinions. (a) Any State, political subdivision, or other interested person may request an advisory... or local requirements, or proposed requirements, as preempted. (1) Such an advisory opinion may be...

  14. 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: W....../inflammation on the brain, alterations of the microbiome, genetics, or other environmental factors.......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...... identified all individuals born in Denmark 1985-2002 (N = 1 015 447) and studied the association between infections treated with anti-infective agents and the subsequent risk of schizophrenia and affective disorders during 1995-2013. Cox regression analyses were adjusted for important confounders. RESULTS...

  15. 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

  16. 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...

  17. 75 FR 32189 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety...

    Science.gov (United States)

    2010-06-07

    ..., GlaxoSmithKline, a drug approved for blood glucose control in adults with type 2 diabetes mellitus. Data... Outcome and Regulation of Glycemia in Diabetes (RECORD) Trial, observational data, health claims data, and...

  18. 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.

  19. 78 FR 63224 - Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... Information: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., application submitted by Bristol-Myers Squibb Co. and (2) MK-3475, application submitted by Merck Sharp... you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in...

  20. 76 FR 80948 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-27

    ..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31...., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per...

  1. 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

  2. 77 FR 16038 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-19

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver... weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related...

  3. 75 FR 64313 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... risk factors (e.g. diabetes, dyslipidemia, or hypertension). The BMI is a measure of body weight (mass... be made to the contact person on or before November 22, 2010. Oral presentations from the public will...

  4. 77 FR 73471 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA... person on or before December 27, 2012. Oral presentations from the public will be scheduled between...

  5. 77 FR 61609 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2012-N-0001... treatment of Type 1 and Type 2 diabetes mellitus. FDA intends to make background material available to the... submissions may be made to the contact person on or before October 24, 2012. Oral presentations from the...

  6. Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti-Infective Agents: A Systematic Literature Review From the ARITMO Project.

    Science.gov (United States)

    Hazell, Lorna; Raschi, Emanuel; De Ponti, Fabrizio; Thomas, Simon H L; Salvo, Francesco; Ahlberg Helgee, Ernst; Boyer, Scott; Sturkenboom, Miriam; Shakir, Saad

    2017-05-01

    A systematic review was performed to categorize the hERG (human ether-a-go-go-related gene) liability of antihistamines, antipsychotics, and anti-infectives and to compare it with current clinical risk of torsade de pointes (TdP). Eligible studies were hERG assays reporting half-minimal inhibitory concentrations (IC50). A "hERG safety margin" was calculated from the IC50 divided by the peak human plasma concentration (free C max ). A margin below 30 defined hERG liability. Each drug was assigned an "uncertainty score" based on volume, consistency, precision, and internal and external validity of evidence. The hERG liability was compared to existing knowledge on TdP risk (www.credibledrugs.org). Of 1828 studies, 82 were eligible, allowing calculation of safety margins for 61 drugs. Thirty-one drugs (51%) had evidence of hERG liability including 6 with no previous mention of TdP risk (eg, desloratadine, lopinavir). Conversely, 16 drugs (26%) had no evidence of hERG liability including 6 with known, or at least conditional or possible, TdP risk (eg, chlorpromazine, sulpiride). The main sources of uncertainty were the validity of the experimental conditions used (antihistamines and antipsychotics) and nonuse of reference compounds (anti-infectives). In summary, hERG liability was categorized for 3 widely used drug classes, incorporating a qualitative assessment of the strength of available evidence. Some concordance with TdP risk was observed, although several drugs had hERG liability without evidence of clinical risk and vice versa. This may be due to gaps in clinical evidence, limitations of hERG/C max data, or other patient/drug-specific factors that contribute to real-life TdP risk. © 2016, The American College of Clinical Pharmacology.

  7. Chalcone scaffolds as anti-infective agents: structural and molecular target perspectives.

    Science.gov (United States)

    Mahapatra, Debarshi Kar; Bharti, Sanjay Kumar; Asati, Vivek

    2015-08-28

    In recent years, widespread outbreak of numerous infectious diseases across the globe has created havoc among the population. Particularly, the inhabitants of tropical and sub-tropical regions are mainly affected by these pathogens. Several natural and (semi) synthetic chalcones deserve the credit of being potential anti-infective candidates that inhibit various parasitic, malarial, bacterial, viral, and fungal targets like cruzain-1/2, trypanopain-Tb, trans-sialidase, glyceraldehyde-3-phosphate dehydrogenase (GAPDH), fumarate reductase, falcipain-1/2, β-hematin, topoisomerase-II, plasmepsin-II, lactate dehydrogenase, protein kinases (Pfmrk and PfPK5), and sorbitol-induced hemolysis, DEN-1 NS3, H1N1, HIV (Integrase/Protease), protein tyrosine phosphatase A/B (Ptp-A/B), FtsZ, FAS-II, lactate/isocitrate dehydrogenase, NorA efflux pump, DNA gyrase, fatty acid synthase, chitin synthase, and β-(1,3)-glucan synthase. In this review, a comprehensive study (from Jan. 1982 to May 2015) of the structural features of anti-infective chalcones, their mechanism of actions (MOAs) and structure activity relationships (SARs) have been highlighted. With the knowledge of molecular targets, structural insights and SARs, this review may be helpful for (medicinal) chemists to design more potent, safe, selective and cost effective anti-infective agents. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  8. 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.

  9. 21 CFR 10.85 - Advisory opinions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Advisory opinions. 10.85 Section 10.85 Food and... PRACTICES AND PROCEDURES General Administrative Procedures § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commissioner on a matter of general applicability. (1...

  10. 21 CFR 12.83 - Advisory opinions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Advisory opinions. 12.83 Section 12.83 Food and... PUBLIC HEARING Hearing Procedures § 12.83 Advisory opinions. Before or during a hearing, a person may, under § 10.85, request the Commissioner for an advisory opinion on whether any regulation or order under...

  11. 78 FR 70954 - Risk Communications Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-11-27

    ...] Risk Communications Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... Communications Advisory Committee. General Function of the Committee: To provide advice and recommendations to.... Visit the Risk Communication Advisory Committee Web site at http://www.fda.gov/AdvisoryCommittees...

  12. Starch-Chitosan Polyplexes: A Versatile Carrier System for Anti-Infectives and Gene Delivery

    Directory of Open Access Journals (Sweden)

    Hanzey Yasar

    2018-03-01

    Full Text Available Despite the enormous potential of nanomedicine, the search for materials from renewable resources that balance bio-medical requirements and engineering aspects is still challenging. This study proposes an easy method to make nanoparticles composed of oxidized starch and chitosan, both isolated from natural biopolymers. The careful adjustment of C/N ratio, polymer concentration and molecular weight allowed for tuning of particle characteristics. The system’s carrier capability was assessed both for anti-infectives and for nucleic acid. Higher starch content polyplexes were found to be suitable for high encapsulation efficiency of cationic anti-infectives and preserving their bactericidal function. A cationic carrier was obtained by coating the anionic polyplex with chitosan. Coating allowed for a minimal amount of cationic polymer to be employed and facilitated plasmid DNA loading both within the particle core and on the surface. Transfection studies showed encouraging result, approximately 5% of A549 cells with reporter gene expression. In summary, starch-chitosan complexes are suitable carriers with promising perspectives for pharmaceutical use.

  13. Light based anti-infectives: ultraviolet C irradiation, photodynamic therapy, blue light, and beyond

    Science.gov (United States)

    Yin, Rui; Dai, Tianhong; Avci, Pinar; Jorge, Ana Elisa Serafim; de Melo, Wanessa CMA; Vecchio, Daniela; Huang, Ying-Ying; Gupta, Asheesh; Hamblin, Michael R

    2013-01-01

    Owing to the worldwide increase in antibiotic resistance, researchers are investigating alternative anti-infective strategies to which it is supposed microorganisms will be unable to develop resistance. Prominent among these strategies, is a group of approaches which rely on light to deliver the killing blow. As is well known, ultraviolet light, particularly UVC (200–280nm), is germicidal, but it has not been much developed as an anti-infective approach until recently, when it was realized that the possible adverse effects to host tissue were relatively minor compared to its high activity in killing pathogens. Photodynamic therapy is the combination of non-toxic photosensitizing dyes with harmless visible light that together produce abundant destructive reactive oxygen species (ROS). Certain cationic dyes or photosensitizers have good specificity for binding to microbial cells while sparing host mammalian cells and can be used for treating many localized infections, both superficial and even deep-seated by using fiber optic delivered light. Many microbial cells are highly sensitive to killing by blue light (400–470 nm) due to accumulation of naturally occurring photosensitizers such as porphyrins and flavins. Near infrared light has also been shown to have antimicrobial effects against certain species. Clinical applications of these technologies include skin, dental, wound, stomach, nasal, toenail and other infections which are amenable to effective light delivery. PMID:24060701

  14. Light based anti-infectives: ultraviolet C irradiation, photodynamic therapy, blue light, and beyond.

    Science.gov (United States)

    Yin, Rui; Dai, Tianhong; Avci, Pinar; Jorge, Ana Elisa Serafim; de Melo, Wanessa C M A; Vecchio, Daniela; Huang, Ying-Ying; Gupta, Asheesh; Hamblin, Michael R

    2013-10-01

    Owing to the worldwide increase in antibiotic resistance, researchers are investigating alternative anti-infective strategies to which it is supposed microorganisms will be unable to develop resistance. Prominent among these strategies, is a group of approaches which rely on light to deliver the killing blow. As is well known, ultraviolet light, particularly UVC (200-280 nm), is germicidal, but it has not been much developed as an anti-infective approach until recently, when it was realized that the possible adverse effects to host tissue were relatively minor compared to its high activity in killing pathogens. Photodynamic therapy is the combination of non-toxic photosensitizing dyes with harmless visible light that together produce abundant destructive reactive oxygen species (ROS). Certain cationic dyes or photosensitizers have good specificity for binding to microbial cells while sparing host mammalian cells and can be used for treating many localized infections, both superficial and even deep-seated by using fiber optic delivered light. Many microbial cells are highly sensitive to killing by blue light (400-470 nm) due to accumulation of naturally occurring photosensitizers such as porphyrins and flavins. Near infrared light has also been shown to have antimicrobial effects against certain species. Clinical applications of these technologies include skin, dental, wound, stomach, nasal, toenail and other infections which are amenable to effective light delivery. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    Abdelmohsen, Usama Ramadan; Pimentel-Elardo, Sheila M.; Hanora, Amro; Radwan, Mona; Abou-El-Ela, Soad H.; Ahmed, Safwat; Hentschel, Ute

    2010-01-01

    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. PMID:20411105

  16. Development of inhibitors of the 2C-methyl-D-erythritol 4-phosphate (MEP) pathway enzymes as potential anti-infective agents.

    Science.gov (United States)

    Masini, Tiziana; Hirsch, Anna K H

    2014-12-11

    Important pathogens such as Mycobacterium tuberculosis and Plasmodium falciparum, the causative agents of tuberculosis and malaria, respectively, and plants, utilize the 2C-methyl-D-erythritol 4-phosphate (MEP, 5) pathway for the biosynthesis of isopentenyl diphosphate (1) and dimethylallyl diphosphate (2), the universal precursors of isoprenoids, while humans exclusively utilize the alternative mevalonate pathway for the synthesis of 1 and 2. This distinct distribution, together with the fact that the MEP pathway is essential in numerous organisms, makes the enzymes of the MEP pathway attractive drug targets for the development of anti-infective agents and herbicides. Herein, we review the inhibitors reported over the past 2 years, in the context of the most important older developments and with a particular focus on the results obtained against enzymes of pathogenic organisms. We will also discuss new discoveries in terms of structural and mechanistic features, which can help to guide a rational development of inhibitors.

  17. 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...

  18. 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...

  19. Bioprospecting Micromonospora from Kaziranga National Park of India and their anti-infective potential.

    Science.gov (United States)

    Talukdar, Madhumita; Duarah, Aparajita; Talukdar, Shruti; Gohain, Manorama Bura; Debnath, Rajal; Yadav, Archana; Jha, Dhruva K; Bora, Tarun C

    2012-08-01

    Large number of strains was isolated from soils of Kaziranga National Park of North-East India using selective isolation procedure. They were assigned to the genus Micromonospora on the basis of their typical colonial and pigmentation features. The taxonomic identities of the isolates were confirmed on the basis of their molecular characters (16SrDNA). A total of one hundred Micromonospora strains were isolated during the present investigation. The diagnostic cell wall sugar and amino acids were determined from these Micromonospora strains. After preliminary screening most of the isolates exhibited excellent anti-infective activity against human bacterial pathogens Staphylococcus aureas, Bacillus subtilis, Proteus vulgaris, Echerichia coli, Pseudomonas aeroginosa and fungal pathogens Aspergillus niger, Fusarium oxysporum and Candida albicans. Among these isolates one strain designated as HK-10 showed promising activity against human pathogens S. aureas, B. subtilis, P. vulgaris and P. aeroginosa.

  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. Virulence evolution in response to anti-infection resistance: toxic food plants can select for virulent parasites of monarch butterflies.

    Science.gov (United States)

    de Roode, J C; de Castillejo, C Lopez Fernandez; Faits, T; Alizon, S

    2011-04-01

    Host resistance to parasites can come in two main forms: hosts may either reduce the probability of parasite infection (anti-infection resistance) or reduce parasite growth after infection has occurred (anti-growth resistance). Both resistance mechanisms are often imperfect, meaning that they do not fully prevent or clear infections. Theoretical work has suggested that imperfect anti-growth resistance can select for higher parasite virulence by favouring faster-growing and more virulent parasites that overcome this resistance. In contrast, imperfect anti-infection resistance is thought not to select for increased parasite virulence, because it is assumed that it reduces the number of hosts that become infected, but not the fitness of parasites in successfully infected hosts. Here, we develop a theoretical model to show that anti-infection resistance can in fact select for higher virulence when such resistance reduces the effective parasite dose that enters a host. Our model is based on a monarch butterfly-parasite system in which larval food plants confer resistance to the monarch host. We carried out an experiment and showed that this environmental resistance is most likely a form of anti-infection resistance, through which toxic food plants reduce the effective dose of parasites that initiates an infection. We used these results to build a mathematical model to investigate the evolutionary consequences of food plant-induced resistance. Our model shows that when the effective infectious dose is reduced, parasites can compensate by evolving a higher per-parasite growth rate, and consequently a higher intrinsic virulence. Our results are relevant to many insect host-parasite systems, in which larval food plants often confer imperfect anti-infection resistance. Our results also suggest that - for parasites where the infectious dose affects the within-host dynamics - vaccines that reduce the effective infectious dose can select for increased parasite virulence.

  3. 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...

  4. 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...

  5. 76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012

    Science.gov (United States)

    2011-12-20

    ... FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee. April 18, October 18...- 15. CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Analgesic Drugs Advisory February 9... Committee Date(s), if needed, to be determined. Antiviral Drugs Advisory Committee..... May 16-17. Arthritis...

  6. Anti-infective strategies of the future: is there room for species-specific antibacterial agents?

    Science.gov (United States)

    Then, Rudolf L; Sahl, Hans-Georg

    2010-01-01

    Broad-spectrum antibiotics, directed against conserved bacterial targets, are the mainstay of antibacterial therapy. Increasing resistance, however, demands new strategies. Over time a number of therapeutic concepts have evolved, starting out with the use of polyclonal antisera, which were rapidly replaced by the easier to use antibiotics. Other concepts, such as immunotherapy, radioimmunotherapy, anti-virulence agents, phage therapy and others are under evaluation and often limited in application. In the discovery process of new antibiotics in the pharmaceutical industry quite a number of new agents have emerged, which exhibit a surprisingly high degree of species-specificity. None of them has been considered for development so far. Some examples from the literature which show selectivity for Helicobacter pylori, Pseudomonas aeruginosa, Haemophilus influenzae, Staphylococcus aureus, anaerobes, and others, will be discussed here. It is postulated that there is a room for such agents in future antibacterial therapy, e.g. in difficult to treat infections caused by nonfermenters such as multiresistant P. aerugoinosa, Acinetobacter, Enterobacteriaceae, and S.aureus, including MRSA. Their application would include monotherapy as well as combination therapy with other antibiotics, anti-virulence agents or immunotherapy and these possibilities would greatly expand the current anti-infective armamentarium.

  7. γδ-T cells: an unpolished sword in human anti-infection immunity.

    Science.gov (United States)

    Zheng, Jian; Liu, Yinping; Lau, Yu-Lung; Tu, Wenwei

    2013-01-01

    γδ-T cells represent a small population of immune cells, but play an indispensable role in host defenses against exogenous pathogens, immune surveillance of endogenous pathogenesis and even homeostasis of the immune system. Activation and expansion of γδ-T cells are generally observed in diverse human infectious diseases and correlate with their progression and prognosis. γδ-T cells have both 'innate' and 'adaptive' characteristics in the immune response, and their anti-infection activities are mediated by multiple pathways that are under elaborate regulation by other immune components. In this review, we summarize the current state of the literature and the recent advancements in γδ-T cell-mediated immune responses against common human infectious pathogens. Although further investigation is needed to improve our understanding of the characteristics of different γδ-T cell subpopulations under specific conditions, γδ-T cell-based therapy has great potential for the treatment of infectious diseases.

  8. 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.

  9. 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

  10. An Independent Evaluation of a Novel Peptide Mimetic, Brilacidin (PMX30063), for Ocular Anti-Infective

    Science.gov (United States)

    Romanowski, Eric G.; Yates, Kathleen A.; Mah, Francis S.

    2016-01-01

    Abstract Purpose: Brilacidin (BRI), a novel defensin mimetic, was evaluated as an ocular anti-infective. Methods: In vitro: Potency based on MIC90s was compared for 50 Staphylococcus aureus (SA), 50 Staphylococcus epidermidis (SE), and 25 each of Streptococcus pneumonia (SP), Streptococcus viridans (SV), Moraxella (MS), Haemophilus influenzae (HI), Pseudomonas aeruginosa (PA), and Serratia marcescens (SM). In vivo: Using established methods, ocular toxicity was graded with Draize testing. For efficacy testing, both corneas of 24 rabbits were infected with methicillin-resistant S. aureus (MRSA), whereas the corneal epithelium was removed in the left eye. After 4 h, 21 topical drops over 5 h were administered to 4 groups: BRI 0.5%, vancomycin (VAN) 5%, saline, and no treatment. The eyes were clinically graded and the corneas were harvested for colony counts. Results: In vitro: Both SA and SE had the lowest minimum inhibitory concentrations among the bacterial groups. The MIC90s to BRI for SP, SV, MS, HI, PA, and SM were 4, 32, 256, 32, 16, and 128-fold higher, respectively, than SA and SE. In vivo: Draize testing determined BRI 0.5% to be minimally irritating. For abraded corneas, BRI was not statistically different from VAN for reducing MRSA. BRI was bactericidal. For intact corneas, VAN reduced more CFU than BRI. BRI reduced CFU in abraded corneas more than intact corneas suggesting poor corneal penetration. Conclusions: BRI has Gram-positive in vitro activity; topical BRI 0.5% was minimally irritating; and BRI 0.5% was equally efficacious as VAN in a MRSA keratitis model when the corneal epithelium was removed. PMID:26501484

  11. Ultrashort self-assembling Fmoc-peptide gelators for anti-infective biomaterial applications.

    Science.gov (United States)

    McCloskey, Alice P; Draper, Emily R; Gilmore, Brendan F; Laverty, Garry

    2017-02-01

    Biomaterial-related infections have a significant impact on society and are a major contributor to the growing threat of antimicrobial resistance. Current licensed antibiotic classes struggle to breakdown or penetrate the exopolysaccharide biofilm barrier, resulting in sub-therapeutic concentrations of antibiotic at the surface of the biomaterial, treatment failure and increased spread of resistant isolates. This paper focuses for the first time on the ability of ultrashort Fmoc-peptide gelators to eradicate established bacterial biofilms implicated in a variety of medical device infections (Gram-positive: Staphylococcus aureus, Staphylococcus epidermidis and Gram-negative Escherichia coli, Pseudomonas aeruginosa). The effect of increasing the cationicity of FmocFF via addition of di-lysine and di-orntithine was also studied with regard to antibacterial activity. Our studies demonstrated that Fmoc-peptides (FmocFF, FmocFFKK, FmocFFFKK, FmocFFOO) formed surfactant-like soft gels at concentrations of 1% w/v and above using a method of glucono-δ-Lactone pH induction. The majority of Fmoc-peptides (0.5-2% w/v) demonstrated selective action against established (grown for 24 h) biofilms of Gram-positive and Gram-negative pathogens. These results are likely to increase the clinical translation of short-peptide gelator platforms within the area of anti-infective biomaterials including as wound dressings and coatings for prostheses, catheters, heart valves and surgical tubes. In the long term, this will lead to wider treatment choices for clinicians and patients involved in the management of medical device infections and reduce the burden of antimicrobial resistance. Copyright © 2017 European Peptide Society and John Wiley & Sons, Ltd. Copyright © 2017 European Peptide Society and John Wiley & Sons, Ltd.

  12. Anti-Infective Potential of Marine Invertebrates and Seaweeds from the Brazilian Coast

    Directory of Open Access Journals (Sweden)

    Mario Steindel

    2013-05-01

    Full Text Available This manuscript describes the evaluation of anti-infective potential in vitro of organic extracts from nine sponges, one ascidian, two octocorals, one bryozoan, and 27 seaweed species collected along the Brazilian coast. Antimicrobial activity was tested against Staphylococcus aureus (ATCC 25923, Enterococcus faecalis (ATCC 29212, Pseudomonas aeruginosa (ATCC 27853, Escherichia coli (ATCC 25922 and Candida albicans (ATCC 10231 by the disk diffusion method. Antiprotozoal activity was evaluated against Leishmania braziliensis (MHOM/BR/96/LSC96-H3 promastigotes and Trypanosoma cruzi (MHOM/BR/00/Y epimastigotes by MTT assay. Activity against intracellular amastigotes of T. cruzi and L. brasiliensis in murine macrophages was also evaluated. Antiviral activity was tested against Herpes Simplex Virus type 1 (HSV-1, KOS strain by the plaque number reduction assay (IC50. Cytotoxicity on VERO cells was evaluated by the MTT assay (CC50. The results were expressed as SI = CC50/IC50. The most promising antimicrobial results were obtained against S. aureus and C. albicans with Dragmacidon reticulatum. Among the seaweeds, only Osmundaria obtusiloba showed moderate activity against P. aeruginosa. Concerning antiprotozoal activity, Bugula neritina, Carijoa riseii, Dragmaxia anomala and Haliclona (Halichoclona sp. showed the most interesting results, mainly against extracellular promastigote forms of L. braziliensis (66, 35.9, 97.2, and 43.6% inhibition, respectively. Moreover, six species of seaweeds Anadyomene saldanhae, Caulerpa cupressoides, Canistrocarpus cervicornis, Dictyota sp., Ochtodes secundiramea, and Padina sp. showed promising results against L. braziliensis (87.9, 51.7, 85.9, 93.3, 99.7, and 80.9% inhibition, respectively, and only Dictyota sp. was effective against T. cruzi (60.4% inhibition. Finally, the antiherpes activity was also evaluated, with Haliclona (Halichoclona sp. and Petromica citrina showing the best results (SI = 11.9 and SI > 5

  13. 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; Pattinson, Shaun; Pearson, Paul; Pleiss, Mike; Pohlschmidt, Marita; Raymackers, Jean-Marc; Rehmann-Sutter, Christoph; Ruegg, Urs; Rutkowski, Anne; Ryan, Monique; Simonds, Anita; Sweeney, Lee; Tinsley, Jon; Towbin, Jeff; Tulinius, Mar; Verschuuren, Jan; Voit, Thomas; Vroom, Elizabeth; Walter, Maggie; Winberg, Meg; Wong, Brenda; Zoetis, Tracy; Johnston, Louise; Robertson, Agata

    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

  14. 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.

  15. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-28

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Veterinary Medicine 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 an...

  16. 75 FR 65641 - Risk Communication Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-10-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] 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...

  17. 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...

  18. 77 FR 31025 - Risk Communication Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-05-24

    ...] 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...: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration, 10903...

  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. 78 FR 66011 - Allergenic Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-11-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Allergenic Products 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: Allergenic Products Advisory...

  1. 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.

  2. 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.

  3. 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)

  4. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the Brain ... Meetings & Events Media Guide About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA ...

  5. 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.

  6. Study on the corrosion resistance and anti-infection of modified magnesium alloy.

    Science.gov (United States)

    Bai, Ningning; Tan, Cui; Li, Qing; Xi, Zhongxian

    2017-01-01

    In this paper, a low-cost and multifunctional hydroxyapatite (HA)/pefloxacin (PFLX) drug eluting layer is coated on magnesium (Mg) alloy through a simple hydrothermal and dip process. The drug PFLX could provide effective prevention for bone infection and inflammation due to its broad-spectrum antibacterial property. And HA would promote the growth of new bone and further improve the biocompatibility of implants. Besides, both PFLX and HA exhibits excellent corrosion protection for Mg alloy substrate. This coating is of great value for improving the application of Mg alloy as biomaterials.

  7. Intra-specific differentiation of fungal endosymbiont Alternaria longissima CLB44 using RNA secondary structure analysis and their anti-infective potential.

    Science.gov (United States)

    Rao, H C Yashavantha; Satish, Sreedharamurthy

    2016-08-01

    New antimicrobial agents derived from endosymbio-tic fungi with unique and targeted mode of action are crucially rudimentary to combat multidrug-resistant infections. Most of the fungi isolated as endosymbionts show close morphological feature resemblance to plant pathogenic or free-living forms, and it is difficult to differentiate these different lifestyles. A fungal endosymbiont strain CLB44 was isolated from Combretum latifolium Blume (Combretaceae). CLB44 was then identified as Alternaria longissima based on morphological and internal transcribed spacer (ITS) intervening 5.8S rRNA gene sequence analysis. ITS2 RNA secondary structure analysis was carried out using mfold server with temperature 37 °C, and anti-infective potential was determined by MIC and disk diffusion methods. ITS2 RNA secondary structure analysis clearly distinguished endosymbiotic A. longissima CLB44 from free-living and pathogenic A. longissima members in the same monophyletic clade. Secondary metabolites produced effectively inhibited Pseudomonas aeruginosa (25 μg/ml), Escherichia coli (25 μg/ml), methicillin-resistant Staphylococcus aureus (50 μg/ml), Candida albicans (100 μg/ml), and other human pathogens. This study emerges as an innovative finding that explores newly revealed ITS2 RNAs that may be an insight as new markers for refining phylogenetic relations and to distinguish fungal endosymbionts with other free-living or pathogenic forms. A. longissima CLB44, in the emerging field of endosymbionts, will pave the way to a novel avenue in drug discovery to combat multidrug-resistant infections. The sequence data of this fungus is deposited in GenBank under the accession no. KU310611.

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 76 FR 29767 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-23

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency...

  13. 75 FR 55805 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  14. 77 FR 64524 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  15. 77 FR 14529 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-12

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease...

  16. 78 FR 32403 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-30

    ... HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and... meeting. Agenda: On July 22, 2013, the committee will discuss the Assessment of SpondyloArthritis...

  17. 77 FR 13611 - Arthritis Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Meeting AGENCY: Food... of Committee: Arthritis Advisory Committee. General Function of the Committee: To provide advice and...

  18. Evaluation of Novel Antimicrobial Peptides as Topical Anti-Infectives with Broad-Spectrum Activity against Combat-Related Bacterial and Fungal Wound Infections

    Science.gov (United States)

    2017-10-01

    succeeded in developing resistance to a variety of AMPs. 2. Keywords Antimicrobial, peptides, anti-fungal, wounds, burns, bacterial resistance ...against Combat- Related Bacterial and Fungal Wound Infections PRINCIPAL INVESTIGATOR: Louis Edward Clemens Ph.D. CONTRACTING ORGANIZATION: Riptide...Anti-Infectives with Broad- Spectrum Activity against Combat-Related Bacterial and Fungal Wound Infections 5a. CONTRACT NUMBER 5b. GRANT NUMBER

  19. Biomedical applications of synthetic, biodegradable polymers for the development of anti-infective strategies.

    Science.gov (United States)

    Bertesteanu, Serban; Chifiriuc, Mariana Carmen; Grumezescu, Alexandru Mihai; Printza, Atnanasia G; Marie-Paule, Thill; Grumezescu, Valentina; Mihaela, Vlad; Lazar, Veronica; Grigore, Raluca

    2014-01-01

    The emergence of antibiotic resistance in microbial strains is representing one of the major threats to public health worldwide, due to the decreased or total cancelling of the available antibiotics effectiveness, correlated with the slow development of novel antibiotics. Due to their excellent biodegradability and biocompatibility, the synthetic polymers could find a lot of biomedical applications, such as the development of biomaterials with optimized properties and of drug delivery systems. This review is focusing on the applications of synthetic, biodegradable polymers for the improvement of antiinfective therapeutic and prophylactic agents (i.e., antimicrobial and anti-inflammatory agents and vaccines) activity, as well as for the design of biomaterials with increased biocompatibility and resistance to microbial colonization.

  20. [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

  1. 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

  2. Display technology on filamentous phage in the search for anti-infective biological agents

    Directory of Open Access Journals (Sweden)

    Nelson Santiago Vispo

    2016-01-01

    Full Text Available Introduction: The causes of antibiotic resistance are complex. The phage display technology has been used mainly to produce monoclonal antibodies (MAbs and peptides directed against cancer or inflammatory disease targets. Today, this technology 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 the phage display technology to discover new drugs against infectious diseases, with a focus on antimicrobial peptides and antibodies. Methods: Basic and recent literature review was made, mainly focused on general aspects of phage display technology and the application in the search of new peptides or antibodies of pharmaceutical use to combat the infectious diseases transmitted by bacteria and virus. Results: Updated information on the selected topics is shown, with a guiding and practical approach aimed at researchers in the field of molecular biology to continue deepening the technology with special emphasis in the applications that have been developed in Cuba. Conclusions: Advances in methods of screening, manufacturing, and humanization technologies show that phage display technology can significantly contribute in the fight against clinically important pathogens.

  3. 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.

  4. 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.

  5. 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

  6. 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.

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

    Science.gov (United States)

    Sadeghi, Babak

    2014-01-01

    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.

  8. 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.

  9. 76 FR 18768 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-05

    ... 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... public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of...

  10. 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...

  11. 77 FR 73472 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General...

  12. 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...

  13. 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...

  14. 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...

  15. 21 CFR 14.84 - Nominations and selection of nonvoting members of standing technical advisory committees.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Nominations and selection of nonvoting members of... Advisory Committees § 14.84 Nominations and selection of nonvoting members of standing technical advisory... Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 1503...

  16. 21 CFR 14.100 - List of standing advisory committees.

    Science.gov (United States)

    2010-04-01

    ... emerging food safety, food science, and nutrition issues that FDA considers of primary importance in the... 21 Food and Drugs 1 2010-04-01 2010-04-01 false List of standing advisory committees. 14.100 Section 14.100 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  17. A fully automated on-line preconcentration and liquid chromatography-tandem mass spectrometry method for the analysis of anti-infectives in wastewaters.

    Science.gov (United States)

    Segura, Pedro A; Gagnon, Christian; Sauvé, Sébastien

    2007-12-05

    We developed and validated a novel on-line preconcentration liquid chromatography-tandem mass spectrometry method for the determination of anti-infectives in wastewaters. The presented method preconcentrates 1 mL of sample in a load column using a switching-valve technique. The method was optimized with respect to sample load flow rate, volume of the load column wash and organic solvent content of the load column wash. The sample is cleaned using a 30% organic solvent washing step and then gradually eluted to an analytical column for separation. To compensate for matrix effects, quantitation was performed using standard additions. Confirmation of the presence of the detected compounds was done using a second selective reaction monitoring transition. Method intra-day precision was less than 9% and inter-day precision %R.S.D. varied between 2.5 and 23%. Limits of detection for the selected anti-infective compounds ranged from 13 to 61 ng L(-1). All the target anti-infectives were found in the city of Montréal WWTP effluent in concentrations ranging from 71 to 289 ng L(-1). This automated method eases the rapid quantitation of those trace contaminants using small sample volumes.

  18. 78 FR 104 - Advisory Committees; Tentative Schedule of Meetings for 2013

    Science.gov (United States)

    2013-01-02

    ... determined. Medical Devices Dispute Resolution Date(s), if needed, to be Panel. determined. Microbiology... determined. Medical Imaging Drugs Advisory February 14 and May date to be Committee. determined... March 4-5, July 9. Health Drugs. [[Page 105

  19. Anti-infective activity of apolipoprotein domain derived peptides in vitro: identification of novel antimicrobial peptides related to apolipoprotein B with anti-HIV activity

    Directory of Open Access Journals (Sweden)

    McKnight Áine

    2010-03-01

    Full Text Available Abstract Background Previous reports have shown that peptides derived from the apolipoprotein E receptor binding region and the amphipathic α-helical domains of apolipoprotein AI have broad anti-infective activity and antiviral activity respectively. Lipoproteins and viruses share a similar cell biological niche, being of overlapping size and displaying similar interactions with mammalian cells and receptors, which may have led to other antiviral sequences arising within apolipoproteins, in addition to those previously reported. We therefore designed a series of peptides based around either apolipoprotein receptor binding regions, or amphipathic α-helical domains, and tested these for antiviral and antibacterial activity. Results Of the nineteen new peptides tested, seven showed some anti-infective activity, with two of these being derived from two apolipoproteins not previously used to derive anti-infective sequences. Apolipoprotein J (151-170 - based on a predicted amphipathic alpha-helical domain from apolipoprotein J - had measurable anti-HSV1 activity, as did apolipoprotein B (3359-3367 dp (apoBdp, the latter being derived from the LDL receptor binding domain B of apolipoprotein B. The more active peptide - apoBdp - showed similarity to the previously reported apoE derived anti-infective peptide, and further modification of the apoBdp sequence to align the charge distribution more closely to that of apoEdp or to introduce aromatic residues resulted in increased breadth and potency of activity. The most active peptide of this type showed similar potent anti-HIV activity, comparable to that we previously reported for the apoE derived peptide apoEdpL-W. Conclusions These data suggest that further antimicrobial peptides may be obtained using human apolipoprotein sequences, selecting regions with either amphipathic α-helical structure, or those linked to receptor-binding regions. The finding that an amphipathic α-helical region of

  20. 76 FR 71033 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2011-11-16

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Tuesday, December 20, 2011 in the Commission Meeting Room, from 1 p...

  1. 78 FR 12059 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-02-21

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ] ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee...) Technological Advisory Council will hold a meeting on Monday, March 11, 2013 in the Commission Meeting Room...

  2. 75 FR 60430 - Federal Advisory Committee; Threat Reduction Advisory Committee

    Science.gov (United States)

    2010-09-30

    ... of the Secretary Federal Advisory Committee; Threat Reduction Advisory Committee AGENCY: Office of... meeting. SUMMARY: Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix... announces a meeting of the Threat Reduction Advisory Committee (hereafter referred to as ``the Committee...

  3. 77 FR 30289 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-05-22

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Wednesday, June 27, 2012 in the Commission Meeting Room, from 1 p.m...

  4. 77 FR 12839 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-03-02

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Wednesday, March 28, 2012 in the Commission Meeting Room, from 1 p...

  5. 75 FR 43156 - Federal Advisory Committee; Missile Defense Advisory Committee

    Science.gov (United States)

    2010-07-23

    ... Office of the Secretary Federal Advisory Committee; Missile Defense Advisory Committee AGENCY: Missile... Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended) and the Government in the Sunshine Act of... Missile Defense Advisory Committee will meet on August 4 and 5, 2010, in Washington, DC. DATES: The...

  6. 78 FR 55255 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-09-10

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council (TAC) will hold a meeting in the Commission Meeting Room to discuss progress on work...

  7. 78 FR 67362 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2013-11-12

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Monday, December 9, 2013 in the Commission Meeting Room, from 1 p.m...

  8. 77 FR 52332 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2012-08-29

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Monday, September 24, 2012 in the Commission Meeting Room, from 1 p...

  9. 76 FR 14009 - Federal Advisory Committee Act; Technological Advisory Council

    Science.gov (United States)

    2011-03-15

    ... COMMISSION Federal Advisory Committee Act; Technological Advisory Council AGENCY: Federal Communications Commission. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Advisory Committee Act... Advisory Council will hold a meeting on Wednesday, March 30, 2011 in the Commission Meeting Room, from 1 p...

  10. 75 FR 30002 - Federal Advisory Committee; Threat Reduction Advisory Committee

    Science.gov (United States)

    2010-05-28

    ... Office of the Secretary Federal Advisory Committee; Threat Reduction Advisory Committee AGENCY: Department of Defense (DoD). ACTION: Renewal of Federal advisory committee. SUMMARY: Under the provisions of the Federal Advisory Committee Act of 1972, (5 U.S.C. Appendix), the Government in the Sunshine Act of...

  11. 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,…

  12. 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 ...

  13. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... About NIDA Director's Page Organization Legislative Activities Advisory Boards & Groups Working at NIDA Donating to NIDA Frequently ... is partly due to the addictive and intoxicating effects of many drugs, which can alter judgment and ...

  14. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  15. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  16. 75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-06-24

    ... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  17. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  18. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  19. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  20. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...

  1. Clinical and microbiological effects of systemic antimicrobials combined to an anti-infective mechanical debridement for the management of aggressive periodontitis: a 12-month randomized controlled trial.

    Science.gov (United States)

    Silva-Senem, Mayra Xavier E; Heller, Débora; Varela, Victor Macedo; Torres, Maria Cynesia Barros; Feres-Filho, Eduardo Jorge; Colombo, Ana Paula Vieira

    2013-03-01

    To compare the 1-year clinical and microbiological outcomes of an enhanced anti-infective therapy with versus without systemic antimicrobials in patients with generalized aggressive periodontitis (GAP). In this 12-month randomized, double-blinded, placebo-controlled trial, 35 individuals assigned to a control (n = 17) or test group (n = 18) received full-mouth supra and subgingival ultrasonic debridement followed by scaling and root planing with chlorhexidine rinsing, brushing, and irrigation. Subjects received either amoxicillin (AMX, 500 mg) + metronidazole (MET, 250 mg) or placebos, TID for 10 days. Subgingival samples were obtained and analysed for their composition by checkerboard. Data were subjected to non-parametric tests. Both therapeutic protocols resulted in similar significant clinical improvement for most parameters at 1 year (p periodontal pathogens decreased, whereas beneficial bacteria increased in counts in both groups over time (p periodontal and other microbial pathogens were associated with disease persistence regardless treatment. The enhanced anti-infective mechanical therapy is comparable with its combination with systemic AMX+MET for most clinical parameters and for maintaining low levels of periodontal pathogens for up to 1 year after treatment of GAP. © 2012 John Wiley & Sons A/S.

  2. 78 FR 64505 - Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products...

    Science.gov (United States)

    2013-10-29

    ... for Tobacco Products. FDA seeks to include the views of women and men, members of all racial and.../default.htm . SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on the Tobacco... Advisory Committee; Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration...

  3. 78 FR 20927 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-08

    ... that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated... HUMAN SERVICES Food and Drug Administration Tobacco Products Scientific Advisory Committee; Notice of... the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory...

  4. 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...

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

    Science.gov (United States)

    2010-02-24

    ...] 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... responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology...

  7. 76 FR 38188 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2011-06-29

    ... 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...

  8. 78 FR 58314 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-09-23

    ... 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...

  9. 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...

  10. 78 FR 58315 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

    Science.gov (United States)

    2013-09-23

    ... 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...

  11. 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...

  12. 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...

  13. 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...

  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. 75 FR 47605 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-06

    ...] 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 Vector Borne Virus Diseases, Division of Viral Products, Office of Vaccines Research and Review...

  16. 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...

  17. 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...

  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. 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...

  20. 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...

  1. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-08

    ...] 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... vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in...

  2. 76 FR 52668 - Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2011-08-23

    ...] Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was... INFORMATION: In the Federal Register of July 22, 2011, FDA announced that a meeting of the Vaccines and...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 75 FR 65640 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-26

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee. General... Branch, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA...

  9. 75 FR 66381 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-10-28

    ...] 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... Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products...

  10. 76 FR 81513 - Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-12-28

    ...] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... meeting will be closed to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory... programs in the Cellular and Tissue Branch, Office of Cellular, Tissue and Gene Therapies, Center for...

  11. 77 FR 63840 - Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-17

    ...] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug... meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory... Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and the Laboratory of...

  12. 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...

  13. 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...

  14. 76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

    Science.gov (United States)

    2011-08-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Arthritis Advisory Committee; Notice of Postponement of... Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011...

  15. 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...

  16. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

    Science.gov (United States)

    Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

    2016-09-12

    This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation

  17. Effect of sputum suction by bronchofiberoscope combined with routine anti-infective therapy on lung function and inflammatory state in patients with severe lung infection

    Directory of Open Access Journals (Sweden)

    Jian Sun

    2016-07-01

    Full Text Available Objective: To analyze the effect of sputum suction by bronchofiberoscope combined with routine anti-infective therapy on lung function and inflammatory state in patients with severe lung infection. Methods: A total of 52 patients with severe lung infection who received treatment in our hospital from January 2015 to December 2015 were selected as research subjects and were divided into observation group 26 cases and control group 26 cases according to different treatment methods. Differences in levels of lung function indexes, serum inflammation-related factors, disease severity-related indexes, JNK/SAPK and TLR2/NF-κB signaling pathways were compared between two groups. Results: FEV1, MMV, MMEF, FRC and TLC values of observation group after treatment were higher than those of control group (P<0.05; serum PAF, MIP-1毩, sTREM-1 and PCT values of observation group were lower than those of control group while APN value was higher than that of control group (P<0.05; serum ACE, NO, ET-1, SP-A and HMGB1 values of observation group were lower than those of control group while CC16 and ChE values were higher than those of control group (P<0.05; JNK, SAPK, TLR2 and NF-κB protein expression levels of observation group were lower than those of control group (P<0.05. Conclusions: Sputum suction by bronchofiberoscope combined with routine anti-infective therapy for patients with severe lung infection has positive significance in improving patients’ lung function, inhibiting systemic inflammation and other aspects.

  18. 5 CFR 2636.103 - Advisory opinions.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Advisory opinions. 2636.103 Section 2636... Advisory opinions. (a) Request for an advisory opinion. (1) An employee may request an advisory opinion... any provision contained in this part. (2) An advisory opinion may not be obtained for the purpose of...

  19. 76 FR 25359 - Science Board Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-05-04

    ... HUMAN SERVICES Food and Drug Administration Science Board Advisory Committee; Notice of Meeting AGENCY... advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory... (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area...

  20. 76 FR 42714 - Science Board Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration Science Board Advisory Committee; Notice of Meeting AGENCY... advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory... desired center or product area. Please call the Information Line for up-to-date information on this...

  1. Drug-Eluting Stents: Do They Increase Heart Attack Risk?

    Science.gov (United States)

    ... intervention, or PCI). Drug-eluting stents have a polymer coating over mesh that emits a drug over ... Advisory Panel meeting on the Absorb Bioresorbable Vascular Scaffold System. JACC: Cardiovascular Interventions. 2016;9:1757. FDA ...

  2. 76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-14

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

  3. 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...

  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. National Weather Service: Watch, Warning, Advisory Display

    Science.gov (United States)

    ... NWS Watch, Warning, Advisory Display NWS Warnings and Advisories on this map become active links to IWIN ... Flood Watch Coastal/Flood Warning Small Stream Flood Advisory Blizzard Warning Winter Storm Watch Winter Storm Warning ...

  6. 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.

  7. 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.

  8. 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

  9. A Placement Advisory Test

    Science.gov (United States)

    Hughes, Chris

    2010-01-01

    The primary method of placement at Portland CC (PCC) is the Compass Placement test. For the most part, students are placed correctly, but there are cases when students feel that they have been placed too low. In such cases we use our newly created Placement Advisory Test (PAT) to help us place them appropriately. (Contains 2 figures.)

  10. 78 FR 70569 - Technical Mapping Advisory Council

    Science.gov (United States)

    2013-11-26

    ...: FEMA-2013-0039] Technical Mapping Advisory Council AGENCY: Federal Emergency Management Agency, DHS... appointment to the Technical Mapping Advisory Council (TMAC). The notice incorrectly stated that contractors...

  11. 76 FR 72954 - Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the...

    Science.gov (United States)

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug...

  12. 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

  13. 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.

  14. 78 FR 77443 - Electricity Advisory Committee

    Science.gov (United States)

    2013-12-23

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee AGENCY: Office of Electricity Delivery and... announces a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L... at: http://energy.gov/oe/services/electricity-advisory-committee-eac . FOR FURTHER INFORMATION...

  15. 76 FR 63664 - Arts Advisory Panel

    Science.gov (United States)

    2011-10-13

    ... Arts Advisory Panel Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that thirteen meetings of the Arts Advisory Panel to the National... States Code. Any person may observe meetings, or portions thereof, of advisory panels that are open to...

  16. 19 CFR 210.79 - Advisory opinions.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Advisory opinions. 210.79 Section 210.79 Customs... ADJUDICATION AND ENFORCEMENT Enforcement Procedures and Advisory Opinions § 210.79 Advisory opinions. (a) Advisory opinions. Upon request of any person, the Commission may, upon such investigation as it deems...

  17. 39 CFR 447.31 - Advisory service.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Advisory service. 447.31 Section 447.31 Postal... Advisory Services and Post-Employment Activities § 447.31 Advisory service. (a) The Ethical Conduct Officer... that responsibility, the Ethical Conduct Officer shall coordinate the advisory service provided by this...

  18. 39 CFR 310.6 - Advisory opinions.

    Science.gov (United States)

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Advisory opinions. 310.6 Section 310.6 Postal... PRIVATE EXPRESS STATUTES § 310.6 Advisory opinions. An advisory opinion on any question arising under this..., 475 L'Enfant Plaza SW., Washington, DC 20260-1100. A numbered series of advisory opinions is available...

  19. 77 FR 59627 - Homeland Security Advisory Council

    Science.gov (United States)

    2012-09-28

    ... SECURITY Homeland Security Advisory Council AGENCY: The Office of Policy, DHS. ACTION: Notice of open teleconference federal advisory committee meeting. SUMMARY: The Homeland Security Advisory Council (HSAC) will... line of the message. Fax: (202) 282-9207. Mail: Homeland Security Advisory Council, Department of...

  20. The Hospitality Education Advisory Committee.

    Science.gov (United States)

    Bloom, Thomas A.

    The use of advisory committees for the development, maintenance, and continued exchange of information for hospitality education programs is discussed. Two types of committees are the general advisory type, which can deal with entire programs on institutional and community levels, and the single-field type, which helps develop programs in specific…

  1. 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.

  2. 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.

  3. 77 FR 55863 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Science.gov (United States)

    2012-09-11

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (12-072)] NASA Advisory Council; Science 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...

  4. 76 FR 64174 - National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory...

    Science.gov (United States)

    2011-10-17

    ... consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to DOT's NHTSA...-0149] National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory... Transportation (DOT). ACTION: Meeting Notice--National Emergency Medical Services Advisory Council. SUMMARY: The...

  5. 77 FR 46802 - National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory...

    Science.gov (United States)

    2012-08-06

    ... consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to DOT's NHTSA...-0100] National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory... Transportation (DOT). ACTION: Meeting Notice--National Emergency Medical Services Advisory Council. SUMMARY: The...

  6. 76 FR 51122 - National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory...

    Science.gov (United States)

    2011-08-17

    ... representatives and consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to...-0115] National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory... Transportation (DOT). Title: National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal...

  7. 77 FR 27278 - National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory...

    Science.gov (United States)

    2012-05-09

    ... consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to DOT's NHTSA...-0050] National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory... Transportation (DOT). ACTION: Meeting notice--National Emergency Medical Services Advisory Council. SUMMARY: The...

  8. 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

  9. 78 FR 38059 - Tobacco Products Scientific Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-06-25

    ...-related disease associated with commercially marketed tobacco products. Before an MRTP can be introduced...] Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Tobacco...

  10. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    2011-09-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel...

  11. 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...

  12. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-04-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

  13. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-10-05

    ... 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; 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...

  14. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-07-19

    ... 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; 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...

  15. 78 FR 19724 - National Institute on Drug Abuse: Notice of Meeting

    Science.gov (United States)

    2013-04-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse: Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the public as...

  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

    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)

  18. 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

  19. 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)

  20. 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

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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...

  7. KZTL 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...

  8. 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.

  9. 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...

  10. paza 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...

  11. 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...

  12. 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...

  13. 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...

  14. 75 FR 25212 - Federal Advisory Committee; Defense Audit Advisory Committee (DAAC)

    Science.gov (United States)

    2010-05-07

    ... DEPARTMENT OF DEFENSE Office of the Secretary Federal Advisory Committee; Defense Audit Advisory..., the Department of Defense announces that the Defense Audit Advisory Committee will meet on May 17... Audit Advisory Committee (DAAC), as required by 41 CFR 102-3.150(a). Accordingly, the Committee...

  15. 77 FR 10798 - Aviation Rulemaking Advisory Committee

    Science.gov (United States)

    2012-02-23

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Aviation Rulemaking Advisory Committee AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of withdrawal of task assignment to the Aviation Rulemaking Advisory Committee (ARAC). SUMMARY: The FAA has withdrawn a task...

  16. 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

  17. 75 FR 67351 - Environmental Management Advisory Board

    Science.gov (United States)

    2010-11-02

    ... Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of Open Teleconference. SUMMARY: This notice announces a teleconference of the Environmental Management Advisory Board (EMAB). The... is to provide the Assistant Secretary for Environmental Management (EM) with advice and...

  18. 78 FR 54629 - Consumer Advisory Board meeting

    Science.gov (United States)

    2013-09-05

    ... From the Federal Register Online via the Government Publishing Office CONSUMER FINANCIAL PROTECTION BUREAU Consumer Advisory Board meeting AGENCY: Bureau of Consumer Financial Protection. ACTION... Consumer Advisory Board (``CAB'' or ``Board'') of the Consumer Financial Protection Bureau (Bureau). The...

  19. 76 FR 3633 - Consumer Advisory Committee

    Science.gov (United States)

    2011-01-20

    ... COMMISSION Consumer Advisory Committee AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: This document announces the rechartering of the Consumer Advisory Committee (hereinafter ``the... ``Commission'') regarding consumer issues within the jurisdiction of the Commission and to facilitate the...

  20. 75 FR 27557 - Federal Advisory Committee Act

    Science.gov (United States)

    2010-05-17

    ... to announce that the Federal Communications Commission (FCC) has renewed the charter for the Advisory... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Federal Advisory Committee Act AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY...

  1. Procedures for setting curve advisory speed.

    Science.gov (United States)

    2009-08-01

    The procedures described in this handbook are intended to improve consistency in curve signing and driver compliance with the advisory speed. The handbook describes guidelines for determining when an advisory speed is needed, criteria for identifying...

  2. 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.

  3. 78 FR 70987 - Proxy Advisory Firm Roundtable

    Science.gov (United States)

    2013-11-27

    ... COMMISSION Proxy Advisory Firm Roundtable AGENCY: Securities and Exchange Commission. ACTION: Notice of... roundtable about proxy 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...

  4. 78 FR 70317 - Invasive Species Advisory Committee

    Science.gov (United States)

    2013-11-25

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory Committee AGENCY..., notice is hereby given of meetings of the Invasive Species Advisory Committee. The purpose of the Advisory Committee is to provide advice to the National Invasive Species Council, as authorized by...

  5. 75 FR 69698 - Invasive Species Advisory Committee

    Science.gov (United States)

    2010-11-15

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of public meetings of the Invasive Species Advisory... of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 30 nonfederal invasive...

  6. 78 FR 11899 - Invasive Species Advisory Committee

    Science.gov (United States)

    2013-02-20

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory Committee AGENCY... notice of public meetings of the Invasive Species Advisory Committee. The document contained incorrect..., March 6, 2013; 9 a.m. to 1:45 p.m. Meeting of the Invasive Species Advisory Committee (OPEN): Thursday...

  7. 76 FR 68776 - Invasive Species Advisory Committee

    Science.gov (United States)

    2011-11-07

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of public meetings of the Invasive Species Advisory... of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 29 nonfederal invasive...

  8. 77 FR 23740 - Invasive Species Advisory Committee

    Science.gov (United States)

    2012-04-20

    ... DEPARTMENT OF THE INTERIOR Office of the Secretary Invasive Species Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of Public Meetings of the Invasive Species Advisory... of meetings of the Invasive Species Advisory Committee (ISAC). Comprised of 30 nonfederal invasive...

  9. 77 FR 74099 - Reestablishment of Advisory Group

    Science.gov (United States)

    2012-12-12

    .... Reestablishing the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health. The Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (Advisory Group), as set... Director of the Office of Management and Budget relating to budgetary, administrative, or legislative...

  10. 77 FR 77247 - Reestablishment of Advisory Commission

    Science.gov (United States)

    2012-12-31

    ... December 31, 2012 Part IV The President Executive Order 13634--Reestablishment of Advisory Commission #0... December 21, 2012 Reestablishment of Advisory Commission By the authority vested in me as President by the.... Reestablishing the President's Advisory Commission on Educational Excellence for Hispanics. The President's...

  11. 77 FR 15091 - Environmental Management Advisory Board

    Science.gov (United States)

    2012-03-14

    ... Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of Solicitation of Nominations for Appointment as a member of the Environmental Management Advisory Board. SUMMARY: In accordance... soliciting nominations for candidates to fill vacancies on the Environmental Management Advisory Board (EMAB...

  12. 76 FR 21877 - Environmental Management Advisory Board

    Science.gov (United States)

    2011-04-19

    ... Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of call for nominations for appointment to the Environmental Management Advisory Board. SUMMARY: This notice constitutes an open call to the public to submit nominations for membership on the Environmental Management Advisory Board. DATES...

  13. 77 FR 10486 - Electricity Advisory Committee Meeting

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee Meeting AGENCY: Office of Electricity Delivery... announces a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L... 20229. FOR FURTHER INFORMATION CONTACT: Matthew Rosenbaum, Office of Electricity Delivery and Energy...

  14. 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 Electricity Delivery and Energy Reliability. ACTION: Notice of open meeting. SUMMARY: This notice announces the open meeting of the re-established DOE Electricity Advisory Committee. The Federal Advisory...

  15. 76 FR 37103 - Electricity Advisory Committee

    Science.gov (United States)

    2011-06-24

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee AGENCY: Office of Electricity Delivery and... a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L...: David Meyer, Office of Electricity Delivery and Energy Reliability, U.S. Department of Energy, Forrestal...

  16. 76 FR 10577 - Electricity Advisory Committee Meeting

    Science.gov (United States)

    2011-02-25

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee Meeting AGENCY: Office of Electricity Delivery... announces a meeting of the reestablished Electricity Advisory Committee (EAC). The Federal Advisory... CONTACT: David Meyer, Office of Electricity Delivery and Energy Reliability, U.S. Department of Energy...

  17. 22 CFR 1429.10 - Advisory opinions.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Advisory opinions. 1429.10 Section 1429.10... AND GENERAL REQUIREMENTS Miscellaneous § 1429.10 Advisory opinions. The Board and the General Counsel will not issue advisory opinions. ...

  18. 5 CFR 2429.10 - Advisory opinions.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Advisory opinions. 2429.10 Section 2429.10 Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY, GENERAL COUNSEL OF THE FEDERAL LABOR....10 Advisory opinions. The Authority and the General Counsel will not issue advisory opinions. ...

  19. 12 CFR 1291.4 - Advisory Councils.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Advisory Councils. 1291.4 Section 1291.4 Banks...' AFFORDABLE HOUSING PROGRAM § 1291.4 Advisory Councils. (a) Appointment. (1) Each Bank's board of directors shall appoint an Advisory Council of 7 to 15 persons who reside in the Bank's District and are drawn...

  20. 24 CFR 1710.17 - Advisory opinion.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Advisory opinion. 1710.17 Section... Advisory opinion. (a) General. A developer may request an opinion from the Secretary as to whether an... requests for Advisory Opinions must be accompanied by the following: (1) A $500.00 filing fee submitted in...

  1. 76 FR 23845 - Arts Advisory Panel

    Science.gov (United States)

    2011-04-28

    ... ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that one meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  2. 76 FR 13996 - Advisory Committee Meeting Notice

    Science.gov (United States)

    2011-03-15

    ... Department of the Army Advisory Committee Meeting Notice AGENCY: Department of the Army, DOD. ACTION: Notice of meeting. SUMMARY: Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as... provisional findings for referral to the Army Education Advisory Committee will follow on 6 April beginning at...

  3. 13 CFR 134.303 - Advisory opinions.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Advisory opinions. 134.303 Section... and NAICS Code Designations § 134.303 Advisory opinions. The Office of Hearings and Appeals does not issue advisory opinions. ...

  4. 75 FR 7255 - Advisory Committee Meeting Notice

    Science.gov (United States)

    2010-02-18

    ... Department of the Army Advisory Committee Meeting Notice AGENCY: Department of the Army, DOD. ACTION: Notice of meeting. SUMMARY: Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as... findings for referral to the Army Education Advisory Committee will follow on 10 March beginning at about...

  5. 5 CFR 1800.3 - Advisory opinions.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Advisory opinions. 1800.3 Section 1800.3 Administrative Personnel OFFICE OF SPECIAL COUNSEL FILING OF COMPLAINTS AND ALLEGATIONS § 1800.3 Advisory opinions. The Special Counsel is authorized to issue advisory opinions only about political activity of...

  6. 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...

  7. 42 CFR 1008.59 - Range of the advisory opinion.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Range of the advisory opinion. 1008.59 Section 1008... AUTHORITIES ADVISORY OPINIONS BY THE OIG Scope and Effect of OIG Advisory Opinions § 1008.59 Range of the advisory opinion. (a) An advisory opinion will state only the OIG's opinion regarding the subject matter of...

  8. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical...

  9. 75 FR 33315 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-11

    ... received by FDA concerning the final rule on the classification of dental amalgam, which published in the... adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory...

  10. 75 FR 8727 - Advisory Commission on Childhood Vaccines; Notice of Meeting

    Science.gov (United States)

    2010-02-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory..., Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C- 26, 5600... Health), and Center for Biologics, Evaluation and Research (Food and Drug Administration). Agenda items...

  11. 75 FR 22147 - Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee...

    Science.gov (United States)

    2010-04-27

    ...] Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee; Notice of... to the public. Name of Committee: Tobacco Product Constituents Subcommittee of the Tobacco Products...: Karen Templeton-Somers, Office of Science, Center for Tobacco Products, Food and Drug Administration...

  12. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-11-07

    ... between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help.... This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation...

  13. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-02-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice... be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of...

  14. 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...

  15. 78 FR 39301 - Committee name: Homeland Security Academic Advisory Council

    Science.gov (United States)

    2013-07-01

    ... leadership on matters relating to student and recent graduate recruitment; international students; academic... Academic Advisory Council AGENCY: Department of Homeland Security. ACTION: Committee Management; Notice of Federal Advisory Committee Meeting. SUMMARY: The Homeland Security Academic Advisory Council (HSAAC) will...

  16. 78 FR 28237 - President's National Security Telecommunications Advisory Committee

    Science.gov (United States)

    2013-05-14

    ... Telecommunications Advisory Committee AGENCY: National Protection and Programs Directorate, DHS. ACTION: Committee... Security Telecommunications Advisory Committee (NSTAC) will meet on Wednesday, May 22, 2013, in Washington..., National Security Telecommunications Advisory Committee, National Protection and Programs Directorate...

  17. 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...

  18. 77 FR 10033 - Advisory Committee International Postal and Delivery Services

    Science.gov (United States)

    2012-02-21

    ... a meeting of the Advisory Committee on International Postal and Delivery Services. This Committee... and delivery services of interest to Advisory Committee members and the public. For further... DEPARTMENT OF STATE [Public Notice: 7762] Advisory Committee International Postal and Delivery...

  19. 44 CFR 208.35 - Reimbursement for Advisory.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Reimbursement for Advisory... Cooperative Agreements § 208.35 Reimbursement for Advisory. DHS will not reimburse costs incurred during an Advisory. ...

  20. 78 FR 11142 - The National Advisory Council on Innovation and Entrepreneurship Meeting of the National Advisory...

    Science.gov (United States)

    2013-02-15

    ... Innovation and Entrepreneurship Meeting of the National Advisory Council on Innovation and Entrepreneurship... National Advisory Council on Innovation and Entrepreneurship (NACIE) has cancelled its open meeting... INFORMATION CONTACT: Nish Acharya, Office of Innovation and Entrepreneurship, Room 70007R, 1401 Constitution...

  1. 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...

  2. 76 FR 52016 - NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting

    Science.gov (United States)

    2011-08-19

    ... consideration by NASA for Commercial Resupply Services for the International Space Station (ISS), with... SPACE ADMINISTRATION NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of...

  3. 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...

  4. Organizing Committee Advisory Committee 187

    Indian Academy of Sciences (India)

    Saha Institute of Nuclear Physics, Kolkata, India. I Mazumdar. Tata Institute of Fundamental Research, Mumbai, India. V Nanal. Tata Institute of Fundamental Research, Mumbai, India. R Palit. Tata Institute of Fundamental Research, Mumbai, India. S Bhattacharya. Variable Energy Cyclotron Centre, Kolkata, India. Advisory ...

  5. Reclaiming Advisory: Advocacy in Action

    Science.gov (United States)

    Bennett, Cory A.; Martin, Kathryn

    2018-01-01

    Exemplary middle schools have a variety of programs that support students' needs and help them adjust socially and emotionally; advisory programs can be one structure to effectively provide some of this support. This article shares the story of how a group of middle level teachers and teacher leaders within a culturally diverse school reclaimed…

  6. 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;…

  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. Prescription drug use in pregnancy and variations according to prior psychiatric history.

    Science.gov (United States)

    Ingstrup, Katja G; Liu, Xiaoqin; Gasse, Christiane; Debost, Jean-Christophe P; Munk-Olsen, Trine

    2018-01-01

    Prescription drug use during pregnancy has increased during the past decades. However, little is known about prescription drug use for high-risk pregnancies. We aimed to estimate the prevalence of redeemed prescriptions in Danish pregnant women with and without previous psychiatric history. A Danish population-based descriptive study of 981 392 pregnancies ending in live-born singletons by 586 988 women aged 15 to 55 years between 1997 and 2012, of which 113 449 (11.6%) pregnancies were by women with a psychiatric history prior to the index pregnancy. All prescription drugs redeemed during pregnancy were identified, and dispensing patterns among the women were reported by therapeutic classes of drugs, calendar year of childbirth, and trimester. Overall, women with psychiatric history prior to pregnancy were more likely to fill a prescription (75.8%; 95% confidence interval [CI], 75.5-76.0%), compared with women with no psychiatric history (64.5%; 95% CI, 64.4-64.6%). The difference was observed even when psychotropic drug use was excluded and in all therapeutic classes except for antineoplastic and immunomodulating drugs. The most commonly prescribed drugs were anti-infectives. Approximately 44.7% (95% CI, 44.5-45.0%) of women with psychiatric history and 31.3% (95% CI, 31.2-31.4%) of women with no psychiatric history redeemed more than one therapeutic class of drugs. Women with a psychiatric history were more likely to redeem prescriptions during pregnancy across almost all drug classes, especially anti-infectives. Two thirds of all women redeemed at least one prescription drug during pregnancy and one third more than one drug class. KEY POINTS We mapped prescription drug use of almost 600 000 women during almost one million pregnancies with focus on women with a history of psychiatric disorder before conception compared with women with no such history. Pregnant women with a previous psychiatric disorder were more likely to redeem prescription drugs compared

  9. [Effects of anti-infection treatment on expressions of HLA-DR and CD86 in dendritic cells in rabbit buccal VX2 squamous cell carcinoma tissue with inflammation].

    Science.gov (United States)

    Lin, Zhang; Nini, Zhang; Guilin, Huang; Xiaohua, Hu; Jie, Yi; Li, Yao

    2015-04-01

    To investigate the effects of anti-infection treatment on the expressions of antigen-presenting-related membrane-surface molecules HLA-DR and CD86 in dendritic cells (DCs) in rabbit buccal VX2 squamous cell carcinoma tissue complicated with local inflammation. Rabbit buccal VX2 squamous cell carcinoma with local inflammation models that were established by inflammation was induced by inoculation VX2 tumor, mechanical trauma, and drinking of milk with high sugar viscosity. The animals were divided into four groups. Group A (n=12): rabbit buccal VX2 squamous cell carcinoma with local inflammation, procaine penicillin was intramuscularly given, and tinidazole tablets were given by gavage for three consecutive days. Group B (n = 12): rabbit buccal VX2 squamous cell carcinoma with local inflammation, normal saline was intramuscularly given, and aspirin were given by gavage for three consecutive days. Group C (n = 12): rabbit buccal VX2 squamous cell carcinoma with local inflammation, normal saline was given intramuscularly and by gavage for three consecutive days. Group D (n = 10): rabbit buccal VX2 squamous cell carcinoma, normal saline was given intramuscularly and by gavage for three consecutive days. All the rabbits were sacrificed for collection of tumor specimens, and the expression levels of membrane-surface HLA-DR and CD86 in DCs of tumor specimens were detected viaflow cytometry. The positive expression rate of HLA-DR and the double positive expression rate of HLA-DR and CD86 were group A > group D > group B > group C. The positive expression rate of CD86 were group A > group D > group B and group C (P < 0.05). Anti-infection treatment significantly increased the expressions of HLA-DR and CD86 in DCs of rabbit buccal VX2 squamous cell carcinoma tissue complicated with local inflammation.

  10. 75 FR 60484 - NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory...

    Science.gov (United States)

    2010-09-30

    ... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (10-115)] NASA Advisory Council; Science Committee; Earth Science Subcommittee; Applied Sciences Advisory Group Meeting AGENCY: National Aeronautics...) announces a meeting of the Applied Science Advisory Group. This Subcommittee reports to the Earth Science...

  11. 75 FR 9184 - Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting

    Science.gov (United States)

    2010-03-01

    ... of the Secretary Federal Advisory Committee; Advisory Council on Dependents' Education; Open Meeting AGENCY: Department of Defense Education Activity (DoDEA). ACTION: Open meeting notice. SUMMARY: Under the... announces that the Advisory Council on Dependents' Education will meet on April 30, 2010, in Wiesbaden...

  12. 75 FR 43493 - Office of the Secretary; Federal Advisory Committee; Defense Intelligence Agency Advisory Board...

    Science.gov (United States)

    2010-07-26

    ... DEPARTMENT OF DEFENSE Office of the Secretary; Federal Advisory Committee; Defense Intelligence Agency Advisory Board; Closed Meeting AGENCY: Defense Intelligence Agency, DOD. ACTION: Meeting notice... Department of Defense announces that Defense Intelligence Agency Advisory Board will meet on September 1 and...

  13. Drug-Induced Nephrotoxicity and Dose Adjustment Recommendations: Agreement Among Four Drug Information Sources

    Science.gov (United States)

    Bicalho, Millena Drumond; Soares, Danielly Botelho; Botoni, Fernando Antonio; Reis, Adriano Max Moreira; Martins, Maria Auxiliadora Parreiras

    2015-01-01

    Hospitalized patients require the use of a variety of drugs, many of which individually or in combination have the potential to cause kidney damage. The use of potentially nephrotoxic drugs is often unavoidable, and the need for dose adjustment should be evaluated. This study is aimed at assessing concordance in information on drug-induced nephrotoxicity and dose adjustment recommendations by comparing four drug information sources (DRUGDEX®, UpToDate®, Medscape® and the Brazilian Therapeutic Formulary) using the formulary of a Brazilian public hospital. A total of 218 drugs were investigated. The global Fleiss’ kappa coefficient was 0.265 for nephrotoxicity (p < 0.001; CI 95%, 0.211–0.319) and 0.346 for recommendations (p < 0.001; CI 95%, 0.292–0.401), indicating fair concordance among the sources. Anti-infectives and anti-hypertensives were the main drugs cited as nephrotoxic by the different sources. There were no clear definitions for qualitative data or quantitative values for dose adjustments among the four information sources. There was no advice for dosing for a large number of the drugs in the international databases. The National Therapeutic Formulary offered imprecise dose adjustment recommendations for many nephrotoxic drugs. Discrepancies among information sources may have a clinical impact on patient care and contribute to drug-related morbidity and mortality. PMID:26371029

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

    Science.gov (United States)

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

    2013-04-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  16. 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)

  17. 76 FR 40929 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2011-07-12

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Tampa, Florida. The... (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on Sunday, September...

  18. 78 FR 42105 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2013-07-15

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Albuquerque, New... Act of 2004 (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on...

  19. 75 FR 50780 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2010-08-17

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Washington, DC. The... (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on Thursday, September...

  20. 77 FR 70807 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2012-11-27

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Washington, DC. The... (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on Thursday, January...

  1. 76 FR 17965 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2011-03-31

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Riverside... Act of 2004 (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on...

  2. 77 FR 28897 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2012-05-16

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Albuquerque, New... Act of 2004 (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on...

  3. 77 FR 47873 - Advisory Board for Exceptional Children

    Science.gov (United States)

    2012-08-10

    ... Bureau of Indian Affairs Advisory Board for Exceptional Children AGENCY: Bureau of Indian Affairs... Advisory Board for Exceptional Children (Advisory Board) will hold its next meeting in Washington, DC The... (IDEA) for Indian children with disabilities. DATES: The Advisory Board will meet on Thursday, September...

  4. 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...

  5. 49 CFR 95.7 - Industry advisory committees: Membership.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Industry advisory committees: Membership. 95.7 Section 95.7 Transportation Office of the Secretary of Transportation ADVISORY COMMITTEES § 95.7 Industry advisory committees: Membership. Each industry advisory committee must be reasonably representative of the...

  6. A Guide for Planning, Organizing, and Utilizing Advisory Councils.

    Science.gov (United States)

    Illinois State Office of Education, Springfield. Div. of Vocational and Technical Education.

    Designed for administrators and teachers at the community college/secondary/elementary levels, the guide is a reference source for establishing and developing citizen advisory councils. A section on Advisory Councils--Planning discusses the need for citizen advisory councils, definition and purpose, advisory council types, and operational…

  7. 49 CFR 604.18 - Request for an advisory opinion.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Request for an advisory opinion. 604.18 Section... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CHARTER SERVICE Advisory Opinions and Cease and Desist Orders § 604.18 Request for an advisory opinion. (a) An interested party may request an advisory opinion from the...

  8. 45 CFR 703.4 - Advisory Committee Management Officer.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 3 2010-10-01 2010-10-01 false Advisory Committee Management Officer. 703.4... OPERATIONS AND FUNCTIONS OF STATE ADVISORY COMMITTEES § 703.4 Advisory Committee Management Officer. (a) The Chief of the Regional Programs Coordination Unit is designated as Advisory Committee Management Officer...

  9. 44 CFR 12.5 - Advisory committee management officer.

    Science.gov (United States)

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Advisory committee management..., DEPARTMENT OF HOMELAND SECURITY GENERAL ADVISORY COMMITTEES § 12.5 Advisory committee management officer. (a) The Director, Records Management Division, Office of Management serves as FEMA's advisory committee...

  10. 34 CFR 300.167 - State advisory panel.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false State advisory panel. 300.167 Section 300.167 Education... DISABILITIES State Eligibility State Advisory Panel § 300.167 State advisory panel. The State must establish and maintain an advisory panel for the purpose of providing policy guidance with respect to special...

  11. 28 CFR 0.129 - Professional Responsibility Advisory Office.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Professional Responsibility Advisory... OF JUSTICE 2-Professional Responsibility Advisory Office § 0.129 Professional Responsibility Advisory Office. (a) The Professional Responsibility Advisory Office is headed by a Director appointed by the...

  12. 13 CFR 130.360 - SBDC advisory boards.

    Science.gov (United States)

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false SBDC advisory boards. 130.360... CENTERS § 130.360 SBDC advisory boards. (a) State/Regional Advisory Boards. (1) The Lead Center must establish an advisory board to advise, counsel, and confer with the SBDC Director on matters pertaining to...

  13. 10 CFR 1045.6 - Openness Advisory Panel.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Openness Advisory Panel. 1045.6 Section 1045.6 Energy... the Restricted Data and Formerly Restricted Data Classification System § 1045.6 Openness Advisory Panel. The DOE shall maintain an Openness Advisory Panel, in accordance with the Federal Advisory...

  14. 36 CFR 219.25 - Science advisory boards.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 2 2010-07-01 2010-07-01 false Science advisory boards. 219... Science advisory boards. (a) National science advisory board. The Forest Service Deputy Chief for Research and Development must establish, convene, and chair a science advisory board to provide scientific...

  15. 32 CFR 1698.5 - Basis of advisory opinions.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Basis of advisory opinions. 1698.5 Section 1698.5 National Defense Other Regulations Relating to National Defense SELECTIVE SERVICE SYSTEM ADVISORY OPINIONS § 1698.5 Basis of advisory opinions. Advisory opinions will be based on the request therefor...

  16. 45 CFR 1321.57 - Area agency advisory council.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Area agency advisory council. 1321.57 Section 1321... advisory council. (a) Functions of council. The area agency shall establish an advisory council. The council shall carry out advisory functions which further the area agency's mission of developing and...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 75 FR 51026 - Environmental Management Advisory Board

    Science.gov (United States)

    2010-08-18

    ... Environmental Management Advisory Board AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Advisory Board (EMAB). The Federal... Assistant Secretary for Environmental Management (EM) with advice and recommendations on corporate issues...

  3. 76 FR 56454 - Consumer Advisory Committee Meeting

    Science.gov (United States)

    2011-09-13

    ... COMMISSION Consumer Advisory Committee Meeting AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: The Commission announces the next meeting date and agenda of its Consumer Advisory Committee (Committee). The purpose of the Committee is to make recommendations to the Commission regarding consumer...

  4. 78 FR 61348 - Electricity Advisory Committee

    Science.gov (United States)

    2013-10-03

    ... DEPARTMENT OF ENERGY Electricity Advisory Committee AGENCY: Department of Energy. ACTION: Notice of Cancellation of Open Meeting. SUMMARY: On September 11, 2013, in FR Doc. 2013-22119, on pages... October 2-3, 2013 of the Electricity Advisory Committee (78 FR 55692). This notice announces the...

  5. 78 FR 26337 - Methane Hydrate Advisory Committee

    Science.gov (United States)

    2013-05-06

    ... DEPARTMENT OF ENERGY Methane Hydrate Advisory Committee AGENCY: Office of Fossil Energy, Department of Energy. ACTION: Notice of Open Meeting. SUMMARY: This notice announces a meeting of the Methane.... SUPPLEMENTARY INFORMATION: Purpose of the Committee: The purpose of the Methane Hydrate Advisory Committee is to...

  6. 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...

  7. 76 FR 59667 - Methane Hydrate Advisory Committee

    Science.gov (United States)

    2011-09-27

    ... DEPARTMENT OF ENERGY Methane Hydrate Advisory Committee AGENCY: Office of Fossil Energy, Department of Energy. ACTION: Notice of Open Meeting. SUMMARY: This notice announces a meeting of the Methane...-5600. SUPPLEMENTARY INFORMATION: Purpose of the Committee: The purpose of the Methane Hydrate Advisory...

  8. 78 FR 37536 - Methane Hydrate Advisory Committee

    Science.gov (United States)

    2013-06-21

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

  9. 77 FR 40032 - Methane Hydrate Advisory Committee

    Science.gov (United States)

    2012-07-06

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

  10. 78 FR 50040 - Technology Advisory Committee

    Science.gov (United States)

    2013-08-16

    ... Trading Commission. ACTION: Notice of Meeting of Technology Advisory Committee. SUMMARY: The Commodity... of the Secretary. Please use the title ``Technology Advisory Committee'' in any written statement you... standardization in the context of SDR data reporting; (2) the Commission's upcoming concept release on automated...

  11. 78 FR 30847 - Forestry Research Advisory Council

    Science.gov (United States)

    2013-05-23

    ... natural resource research issues, and discussion is limited to Forest Service, National Institute of Food... DEPARTMENT OF AGRICULTURE Forest Service Forestry Research Advisory Council AGENCY: Forest Service, USDA. ACTION: Notice of meeting. SUMMARY: The Forestry Research Advisory Council will meet in...

  12. 76 FR 50499 - Arts Advisory Panel

    Science.gov (United States)

    2011-08-15

    ... ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel Pursuant to Section 10(a)(2... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks... financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended...

  13. 77 FR 41808 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-07-16

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  14. 78 FR 64026 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-10-25

    ... 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: Pursuant to Section 10(a)(2) of the... of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks Center...

  15. 77 FR 22613 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-04-16

    ... ARTS AND THE HUMANITIES Arts Advisory Panel Meeting AGENCY: National Endowment for the Arts, National Foundation on the Arts and the Humanities. ACTION: Notice of meeting. SUMMARY: Pursuant to Section 10(a)(2... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  16. 77 FR 13367 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-03-06

    ... 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: Pursuant to Section 10(a)(2) of... of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference at the...

  17. 78 FR 42982 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-07-18

    ... 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: Pursuant to Section 10(a)(2) of... the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks Center...

  18. 77 FR 27803 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-05-11

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  19. 77 FR 13154 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-03-05

    ... 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 Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that a meeting of the Arts...

  20. 78 FR 17942 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-03-25

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  1. 77 FR 61643 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-10-10

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  2. 75 FR 56146 - Arts Advisory Panel; Meetings

    Science.gov (United States)

    2010-09-15

    ... ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel; Meetings Pursuant to... given that four meetings of the Arts Advisory Panel to the National Council on the Arts will be held at... are approximate): Arts Education (application review): October 4-5, 2010 in Room 716. A portion of...

  3. 77 FR 75672 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-12-21

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  4. 78 FR 59978 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-09-30

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  5. 77 FR 35067 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-06-12

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  6. 77 FR 49026 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-08-15

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  7. 77 FR 56875 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2012-09-14

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference from...

  8. 78 FR 26399 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-05-06

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference at...

  9. 76 FR 3677 - Arts Advisory Panel

    Science.gov (United States)

    2011-01-20

    ... ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel Pursuant to Section 10(a)(2... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks..., discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts...

  10. 78 FR 5213 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-01-24

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  11. 78 FR 50451 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-08-19

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  12. 78 FR 28244 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-05-14

    ... 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: Pursuant to Section 10(a)(2) of... meetings of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  13. 78 FR 21978 - Arts Advisory Panel Meeting

    Science.gov (United States)

    2013-04-12

    ... 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: Pursuant to Section 10(a)(2) of... meeting of the Arts Advisory Panel to the National Council on the Arts will be held at the Nancy Hanks...

  14. 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...

  15. 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...

  16. 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...

  17. 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.

  18. 22 CFR 401.28 - Advisory boards.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Advisory boards. 401.28 Section 401.28 Foreign Relations INTERNATIONAL JOINT COMMISSION, UNITED STATES AND CANADA RULES OF PROCEDURE References § 401.28 Advisory boards. (a) The Commission may appoint a board or boards, composed of qualified persons, to...

  19. Non-Alumni Advisory Board Volunteers

    Science.gov (United States)

    Nagai, Judy; Nehls, Kimberly

    2014-01-01

    Advisory boards typically offer guidance, support, social, and financial capital to academic units within colleges and universities. They are generally comprised of prominent volunteers from the community and appropriate industries or businesses. The results of this exploratory study found that non-alumni advisory board volunteers developed…

  20. N-Heterocyclic choline analogues based on 1,2,3,4-tetrahydro(iso)quinoline scaffold with anticancer and anti-infective dual action.

    Science.gov (United States)

    Zablotskaya, Alla; Segal, Izolda; Geronikaki, Athina; Shestakova, Irina; Nikolajeva, Vizma; Makarenkova, Galina

    2017-06-01

    Pharmacological effects of biologically active "small molecules" can be improved by their targeted modification, which affects drug delivery and interaction with tumor cells and microorganisms. We aimed to evaluate anticancer and antimicrobial activity of lipid-like choline derivatives modified via simultaneous introduction of tetrahydro(iso)quinoline based pharmacophore system at nitrogen atom and long chain alkyl substituent at oxygen atom. Target compounds were synthesized under phase-transfer catalysis conditions followed by quaternization, and evaluated for cytotoxicity and NO-generation ability on HT-1080 and MG-22A tumor cell lines and NIH 3T3 normal mouse fibroblasts, and screened for antimicrobial activity against gram-positive (Staphylococcus aureus and Bacillus cereus) and gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa and Proteus mirabilis) and fungi (Candida albicans and Aspergillus niger). Inhibitory action of active compounds towards E. coli DNA gyrase was investigated. Target compounds exhibit high selective cytotoxicity (LC 50 quinoline scaffold, possessing very high cytotoxicity with attendant strong antimicrobial activity are the leads for developing effective dual action therapeutics. Copyright © 2017 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  1. 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...

  2. 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...

  3. 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.

  4. 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 ...

  5. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... Federal Register about last minute modifications that impact a previously announced advisory committee... for the Nucleus Hybrid TM L24 Implant System sponsored by Cochlear Americas. The proposed Indications...

  6. 76 FR 24893 - National Institute on Drug Abuse; Notice of Meeting

    Science.gov (United States)

    2011-05-03

    ... 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. Neonatal adverse drug reactions: an analysis of reports to the French pharmacovigilance database.

    Science.gov (United States)

    Kaguelidou, Florentia; Beau-Salinas, Frédérique; Jonville-Bera, Annie Pierre; Jacqz-Aigrain, Evelyne

    2016-10-01

    Term and preterm neonates are at high risk for serious adverse drug reactions (ADRs). A descriptive study of reports registered in the French pharmacovigilance database from 1986 to 2012 were obtained. All reports concerning neonates (≤1 month of life) with direct drug exposure were retrieved. Characteristics of the reports, including reported ADR(s), drug(s) and the causality assessment using the French causality assessment method, were described. A total of 1688 reports were analyzed and more than half of them were classified as serious (n = 995). Median age at ADR occurrence was 9 days. Overall, 3127 ADRs were described in these reports in relation to 2238 suspect/interacting drugs. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%) and blood and lymphatic system disorders (12%). In the majority of ADRs reported (73%), infants fully recovered and less than 4% of neonates deceased as a consequence of the reported ADR. One out of five ADRs was associated with drug administration errors. Therapeutic classes commonly incriminated were anti-infectives, nervous system and alimentary tract drugs. Substances most frequently related to serious ADRs were zidovudine, ibuprofen and nevirapine. Among the 10 most frequently encountered drug-ADR pairs, two substances were mainly implicated, zidovudine in haematological adverse reactions and phytomenadione in maladministrations. Anti-infective drugs, mainly antiretroviral therapy, account for the majority of ADRs reported in neonates. The specific issue of drug maladministration and medication errors remains to be addressed in neonates. © 2016 The British Pharmacological Society.

  16. 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 ...

  17. 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 ...

  18. 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 ...

  19. 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...

  20. National Environmental Justice Advisory Council Current Charges

    Science.gov (United States)

    The National Environmental Justice Advisory Council (NEJAC) provides advice and recommendations about broad, cross-cutting issues related to environmental justice, from all stakeholders involved in the environmental justice dialogue.

  1. 78 FR 38297 - Science Advisory Board (SAB)

    Science.gov (United States)

    2013-06-26

    ... Public Administration Report: Forecasting the Future- Assuring the Capacity of the National Weather... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Science Advisory Board (SAB) AGENCY: Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration...

  2. 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.

  3. Scientific Advisory Board FY92 Annual Report.

    Science.gov (United States)

    1993-03-01

    Implementation Board for the North American Waterfowl Management Plan; Chairman, Chief of Engineers’ Environmental Advisory Board. Awards: Aldo ... Leopold Medal, Wildlife Society; Barbara Swain Medal, Natural Resources Council of America. Authored numerous papers and reports, assisted editing and

  4. the Pathways to Resilience Project Advisory Panel

    African Journals Online (AJOL)

    or informal, naturally ... Keywords: advisory panel; collaboration; community; participatory; partnership; resilience; youth. In a country such ... interventions, increased researcher and community knowledge and use of local re- sources, and skill ...

  5. 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...

  6. 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...

  7. 77 FR 5578 - Founding Fathers Advisory Committee

    Science.gov (United States)

    2012-02-03

    ... Fathers Advisory Committee. The Committee will advise the Archivist of the United States on the progress...: National Archives and Records Administration, 700 Pennsylvania Avenue NW., Archivist's Board Room, Room 119...

  8. Controller Response to Conflict Resolution Advisory

    Science.gov (United States)

    1992-12-01

    Conflict Resolution Advisory (CRA) is an automated software aid for air traffic : control specialists at air route traffic control centers (ARTCCs). CRA calculates, : validates, and displays to the en route controller a single resolution for predicte...

  9. Controller Response to Conflict Resolution Advisory Prototype

    Science.gov (United States)

    1991-01-01

    Conflict Resolution Advisory (CRA) is an automated software aid for air traffic : control specialists at air route traffic control centers (ARTCCs). CRA calculates, : validates, and displays to the en route controller a single resolution for predicte...

  10. 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.

  11. 77 FR 55218 - Homeland Security Advisory Council

    Science.gov (United States)

    2012-09-07

    ... environment; evolving threats in cyber security; Transportation Security Administration operations; DHS... associated with airport security. Specifically, there will be material presented regarding the latest viable... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2012-0055] Homeland Security Advisory Council...

  12. 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...

  13. Improving highway advisory radio predictability and performance

    Science.gov (United States)

    2011-01-01

    Highway Advisory Radio (HAR) stations, sometimes referred to as Travelers Information Stations (TIS), : allow highway agencies to broadcast important messages about traffic, weather and roadway conditions to : motorists. Caltrans has deployed HAR ...

  14. 77 FR 26274 - Nuclear Energy Advisory Committee

    Science.gov (United States)

    2012-05-03

    ... Energy Advisory Committee (NEAC). The Federal Advisory Committee Act (Pub. Law 92-463, 86 Stat. 770..., 2012; 8:30 a.m.-4:00 p.m. ADDRESSES: L'Enfant Plaza Hotel, 480 L'Enfant Plaza SW., Washington, DC 20024... committee business. For updates, one is directed to the NEAC Web site: http://www.ne.doe.gov/neac/neNeac...

  15. 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

  16. 76 FR 15043 - National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory...

    Science.gov (United States)

    2011-03-18

    ... consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to the U.S. DOT's.... NHTSA-2011-0038] National Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal... Transportation (DOT). ACTION: Meeting Notice--National Emergency Medical Services Advisory Council. SUMMARY...

  17. 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...

  18. 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...

  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...