U.S. FDA advisory meetings through Dec 15
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS EDT/GMT UNTIL NOV. 7 WHEN EST/GMT RESUMES.
For more information on the FDA's Advisory Committee meetings, see: here (Adds September cardiology panel meeting)
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE
DATE: Aug. 30, 0830/1230
LOCATION: Marriott, 9751 Washingtonian Blvd., Gaithersburg, Md.
CONTACT: Cristi Stark, 1-877-287-1373 (choose option 4)
The committee will receive a report from the Tobacco Product Constituents Subcommittee and discuss a proposed initial list of harmful or potentially harmful constituents, the rationale for inclusion of each constituent, established analytical methods as well as the ancillary methods and normalization standards for the identified constituents.
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: Sept. 7, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Minh Doan, 301-796-9001
The committee will discuss Forest Laboratories Inc (FRX.N) subsidiary Cerexa Inc's injectable antibiotic ceftaroline fosamil for 1) adults with community acquired bacterial pneumonia and 2) complicated skin and skin structure infections.
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE: Sept. 14, 0800/1200
LOCATION: Marriott Inn and Conference Center, 3501 University Blvd. East, Adelphi, Md.
CONTACT: Elaine Ferguson, 301-827-7001
The committee will discuss the abuse potential of the drug dextromethorphan and the public health benefits and risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug products. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for dextromethorphan in response to the increased incidence of abuse, especially among adolescents.
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE
DATE: Sept 15-16, 0800/1200
LOCATION: The Marriott Inn and Conference Center, University of Maryland University College, 3501 University Blvd. East, Adelphi, Md.
CONTACT: Paul Tran, 301-796-9001
On Sept. 15, the committee will discuss the results of the Sibutramine Cardiovascular Outcomes Trial (SCOUT) for Abbott Laboratories Inc's (ABT.N) Meridia (sibutramine hydrochloride monohydrate) for treatment of obesity. The SCOUT study was a randomized, double-blind, placebo-controlled trial. The preliminary results of the SCOUT trial indicated that clinical trial participants who received Meridia instead of placebo had a higher incidence of major cardiovascular adverse events that was statistically significant.
On Sept. 16, the committee will discuss the safety and efficacy of a new drug application from Arena Pharmaceuticals Inc (ARNA.O) for lorcaserin hydrochloride, with the proposed trade name Lorqess as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) of equal to or greater than 30 kilograms per square meter, or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related co-morbidities, which include high blood pressure, heart disease or diabetes.
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: Sept. 16, 0830/1230
LOCATION: FDA White Oak campus, 10903 New Hampshire Ave., Building 31, White Oak Conference Center, room 1503, Silver Spring, Md.
CONTACT: Yvette Waples, 301-796-9001
The committee will discuss the available safety and efficacy data for a supplemental new drug application from Alkermes Inc (ALKS.O) for Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opioid dependence.
VETERINARY MEDICINE ADVISORY COMMITTEE
DATE: Sept. 19, 1300/1700 and Sept. 20, 0800/1200
LOCATION: Hilton, 1750 Rockville Pike, Rockville, Md.
CONTACT: Aleta Sindelar, 240-276-9004
On Sept. 19, the committee will receive an orientation on both general scientific issues surrounding genetically engineered animals and the statutory and regulatory constraints under which the agency must operate. On Sept. 20, the committee will consider issues regarding Aqua Bounty Technologies Inc's (ABTX.L) AquAdvantage salmon, a genetically engineered Atlantic salmon intended to grow faster than conventionally bred Atlantic salmon.
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
DATE: Sept. 20, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Anuja Patel, 301-796-9001
The committee will discuss a new drug application from Boehringer Ingelheim for dabigatran etexilate mesylate capsules for the proposed indication of prevention of stroke in patients with atrial fibrillation.
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
DATE: Sept. 21, 1400/1800
LOCATION: National Institutes of Health, Building 29B/Conference Room C, 9000 Rockville Pike, Bethesda, Md.
CONTACT: Christine Walsh or Denise Royster, 301-827-0314
The committee will hear updates of the research programs from various laboratories at the Center for Biologics Evaluation and Research, including the Laboratory of Respiratory and Special Pathogens in the Division of Bacterial, Parasitic, and Allergenic Products; the Laboratory of Hepatitis Viruses as well as the Laboratory of Vector Borne Virus Diseases in the Division of Viral Products.
RADIOLOGICAL DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Sept. 24, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Shanika Craig, 301-796-6639
The committee will discuss, make recommendations and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic Inc (HOLX.O). The Selenia C Digital Breast Tomosynthesis System is intended for use in the same clinical applications as traditional mammographic systems.
MENTHOL REPORT SUBCOMMITTEE OF THE TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE
DATE: Sept. 27, 0900/1300
LOCATION: Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Blvd., Rockville, Md.
CONTACT: Cristi Stark, 877-287-1373 (choose option 4)
The subcommittee will receive a presentation and discuss the timelines and structure of the Tobacco Products Scientific Advisory Committee's required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.
GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Nov. 18, 0800/1300
LOCATION: Holiday Inn, 10000 Baltimore Ave., College Park, Md.
CONTACT: Margaret McCabe-Janicki, 301-796-7029
The committee will discuss, make recommendations and vote on MELA Sciences Inc's (MELA.O) MelaFind. The device is a computer-controlled multispectral dermoscope that uses light to image the skin through a thin layer of liquid (alcohol or oil). A complementary metal oxide semiconductor digital camera inside the probe captures the images and then differentiates them among pigmented skin lesions for melanoma risk using predefined software statistical pattern recognition algorithms.
DENTAL PRODUCTS PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: Dec 14-15, 0800/1300
LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.
CONTACT: Olga Claudio, 301-796-7608
The committee will discuss and make recommendations on scientific issues raised in petitions received by FDA concerning the final rule on the classification of dental amalgam, which published in the Federal Register on August 4, 2009. Issues raised in the petitions include the adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on risk assessments issued by the National Academy of Sciences, entitled "Science and Decisions: Advancing Risk Assessment," NAP, 2009. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)