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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 1/16/20-1/16/20

Meeting Details:

The committee will discuss new drug application (NDA) 204803, bupivacaine extended-release solution for instillation, submitted by DURECT Corp., for the proposed indication of post-surgical analgesia. The committee will discuss whether the Applicant adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for post-surgical analgesia and the appropriateness of the proposed patient populations. The committee will also be asked to discuss the approvability of this product.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/15/20-1/15/20

Meeting Details:

During the morning session, the committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

During the afternoon session, the committees will discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product.

 

       
Location: White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products and DSRM AdComm

Meeting Date: 1/14/20-1/14/20

Meeting Details:

The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.

 

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

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Past Meetings

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