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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the FDA

Meeting Date: 5/18/09-5/18/09

Meeting Details:

The Science Board will hear about and discuss updates from the following subcommittees: (1) The review of each Center's projects within scientific priority areas, (2) the review of research at the Center for Veterinary Medicine, and (3) the review of FDA's scientific information technology infrastructure modernization initiatives. The Science Board will also hear updates on rapid detection of Salmonella in foods and the handling of biospecimens used for genomic and proteomic analyses.

 

       
Location: Hilton Rockville MD Related News Links: Not Available
Time: 9:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the Food and Drug Administration

Meeting Date: 10/31/08-10/31/08

Meeting Details:

The Science Board will hear about and discuss a review of the draft assessment of Bisphenol A (BPA) for use in food contact applications by the Science Board BPA Subcommittee. The Science Board will discuss 2009 agenda topics. The Science Board will also hear an overview of current methods for detection of contaminants in FDA-regulated products.

 

       
Location: Hilton Hotel Washington DC North Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting of the Bisphenol A Subcommittee of the Science Board

Meeting Date: 9/16/08-9/16/08

Meeting Details:

The Subcommittee will hear and discuss the draft assessment of BPA for use in food contact applications, including oral presentations from the public. Meeting materials including FDA’s draft assessment of BPA and FDA’s charge to the Subcommittee will be posted on or after August 15, 2008.

 

       
Location: Hilton Washington, WashingtonDC/Rockville Executive Meeting Center, Plaza Ballroom 1750 Rockville Pike Rockville MD 20852 Related News Links: Not Available
Time: 9:00AM-3:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the Food and Drug Administration

Meeting Date: 5/30/08-5/30/08

Meeting Details:

The Science Board will hear about and discuss a subcommittee review of the National Center for Toxicological Research and Office of Regulatory Affairs. The Science Board will discuss keeping pace with technical and scientific evolutions in the fields of regulatory science. The Science Board will also hear about and discuss updates on a subcommittee review of the agency’s science programs and infrastructure from the June 14, 2007, and December 3, 2007, Science Board meetings.

 

       
Location: Gaithersburg Hilton Related News Links: Not Available
Time: 8:00AM-2:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the FDA

Meeting Date: 12/3/07-12/3/07

Meeting Details:

The Science Board will hear about and discuss the agency's critical path program. The Science Board will hear about and discuss updates on the National Antimicrobial Resistance Monitoring System (NARMS) Program and activities related to melamine from the March 31, 2006, and June 14, 2007, Science Board meetings. The Science Board will then hear about and discuss the subcommittee review of the agency's science programs. The Science Board will also hear about and discuss the agency's updates on drug safety.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the FDA

Meeting Date: 6/14/07-6/14/07

Meeting Details:

The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board

Meeting Date: 3/31/06-3/31/06

Meeting Details:

The Science Board will conclude their discussion on drug safety from the meeting of November 4, 2006, and will hear about and discuss a request by the agency for a review of the agency's science programs. The Science Board will then hear about and discuss the agency's response to the recommendations contained in the Science Board's peer review of the Office of Regulatory Affairs Pesticide Program, plans for a Science Board peer review of the Center for Veterinary Medicine's intramural portion of the National Antimicrobial Resistance Monitoring System, and the science priorities of the agency's Office of Women's Health .

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the FDA

Meeting Date: 11/4/05-11/4/05

Meeting Details:

The Science Board will hear about and discuss the following topics: (1) An update on activities of the Drug Safety Oversight Board, (2) the agency's Bioresearch Monitoring Initiative, and (3) the Board's science peer review activities, including presentation of the Board's peer review of the Office of Regulatory Affairs' pesticide monitoring program.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board

Meeting Date: 4/15/05-4/15/05

Meeting Details:

The Science Board will hear about and discuss (1) the agency’s pre- and post-marketing safety programs for drugs and biologics and (2) Good Manufacturing Practices for vaccines, blood and cell, tissue and gene products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board

Meeting Date: 11/5/04-11/5/04

Meeting Details:

The Board will hear about and discuss: (1) An update on the FDA Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath/), including an overview of docket submissions, current status, reports on related activities (Medical Technology Innovation Task Force and Foods Critical Path White Paper), and future plans; (2) FDA's final report on pharmaceutical current good manufacturing practices (http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm); and (3) an internal peer review of the Office of Regulatory Affairs' pesticide program, including plans for the establishment of a Science Board subcommittee to conduct an external program peer review.

 

       
Location: FDA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board Meeting

Meeting Date: 4/22/04-4/22/04

Meeting Details:

The committee will hear about and discuss the FDA's obesity working group report and critical task white paper.

 

       
Location: FDA - Rockville Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the Food and Drug Administration

Meeting Date: 11/6/03-11/6/03

Meeting Details:

The Board will hear about and discuss FDA's Food Security Program.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board

Meeting Date: 4/9/03-4/9/03

Meeting Details:

The board will hear and discuss the FDA's launched initiative to improve the development and availability of innovative medical products, specifically in the area of pharmacogenomics. The board will also hear updates on the pharmaceutical manufacturing initiative.

 

       
Location: FDA Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board Meeting

Meeting Date: 11/16/01-11/16/01

Meeting Details:

The board will discuss external science review for FDA's Center for Devices and Radiological Health, emerging issues in FDA's oversight of clinical research, and emerging issues in pharmaceutical manufacturing.

 

       
Location: FDA Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the Food and Drug

Meeting Date: 4/13/01-4/13/01

Meeting Details:

Open committee discussion, 8:30 a.m. to 1 p.m.; open public hearing, 1 p.m. to l:30 p.m.; open committee discussion, 1:30 p.m. to 4:30 p.m. The board will hear and discuss programmatic peer review for the FDA's Center for Devices and Radiological Health. The committee will also discuss: (1) The FDA's Office of Women's Health research plan; (2) an overview of tissue and tissue engineered products; and (3) strategies to meet scientific workforce challenges.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board

Meeting Date: 10/21/98-10/21/98

Meeting Details:

To provide advice and recommendations to the agency on FDA's regulatory issues. At least one portion of the meeting will be closed.

 

       
Location: Washinton Plaza Hotel Washington, DC Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 12/10/19-12/10/19

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 022034, for vernakalant HCl solution, for intravenous injection, submitted by Correvio International Sàrl, for the proposed indication of rapid conversion of recent onset atrial fibrillation to sinus rhythm for non-surgery patients: Atrial fibrillation = 7 days duration, and for post-cardiac surgery patients: Atrial fibrillation = 3 days duration.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Amarin Pharma Inc.

Meeting Date: 11/14/19-11/14/19

Meeting Details:

The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: To reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)”

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm - Sponsor: Boehringer Ingelheim

Meeting Date: 11/13/19-11/13/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: As an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/8/19-11/8/19

Meeting Details:

On November 8, 2019, the Center for Biologics Evaluation and Research's (CBER) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the development of chikungunya vaccines.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral Hospital and Personal Use Devices Panel

Meeting Date: 11/6/19-11/7/19

Meeting Details:

On November 6 and 7, 2019, the committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices. The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes.

 

       
Location: Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic AdComm
Sponsor: Agile Therapeutics, Inc.

Meeting Date: 10/30/19-10/30/19

Meeting Details:

The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm
Sponsor: AMAG Pharmaceuticals

Meeting Date: 10/29/19-10/29/19

Meeting Details:

The committee will discuss supplemental new drug application (sNDA 021945/S-023#) for MAKENA (hydroxyprogesterone caproate injection, 250 milligrams per milliliter) manufactured by AMAG Pharmaceuticals. In 2011, MAKENA received approval under the accelerated approval pathway (21 CFR part 314, subpart H, and section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. MAKENA was shown in the preapproval clinical trial to reduce the proportion of women who delivered at less than 37 weeks gestation, a surrogate endpoint that FDA determined was reasonably likely to predict a clinical benefit of preterm birth prevention, such as improved neonatal mortality and morbidity. As required under 21 CFR 314.510, the Applicant conducted a postapproval confirmatory clinical trial to verify and describe clinical benefit. AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity. The committee will consider the trial's findings and the sNDA in the context of AMAG Pharmaceuticals' confirmatory study obligation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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