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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    
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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 OptionsNeurological Devices Panel - Sponsor: Sequent Medical, Inc.

Meeting Date: 9/27/18-9/27/18

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Meeting Details:

On September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation. The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT): a multicenter, prospective, non-randomized investigation. The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm - Sponsor: Genentech & Celltrion

Meeting Date: 10/10/18-10/10/18

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Meeting Details:

The committee will discuss biologics license application 761088 for CT-P10, a proposed biosimilar to Genentech, Inc.'s RITUXAN (rituximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B- cell Non-Hodgkin's Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to CT-P10 in combination with chemotherapy, as single- agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: Trevena Inc.

Meeting Date: 10/11/18-10/11/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will also be asked to discuss the efficacy and safety data and benefit-risk considerations.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm - Sponsor: AcelRX

Meeting Date: 10/12/18-10/12/18

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Meeting Details:

The committee will be asked to discuss new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk- benefit considerations and whether this product should be approved.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Gastrointestinal & DSRM AdComm - Sponsor: Sloan Pharma

Meeting Date: 10/17/18-10/17/18

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Meeting Details:

The committees will discuss supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.[agrave].r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm - Sponsor: Shire

Meeting Date: 10/18/18-10/18/18

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Meeting Details:

The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults.

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 10/24/18-10/25/18

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Meeting Details:

Agenda: On both days, the committee will discuss the ``Guidance for Industry: Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes' (https://www.fda.gov/downloads/Drugs/Guidances/ucm071627.pdf), and the cardiovascular risk assessment of drugs and biologics for the treatment of type 2 diabetes mellitus.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsPharmaceutical Science and Clinical Pharmacology AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

The meeting will focus on two topics related to the Office of Pharmaceutical Quality’s priority of promoting the availability of better medicine. During the morning session, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. FDA will seek input on the potential enhancement of a submission format consistent with KASA to improve the efficiency and consistency of regulatory quality assessment. During the afternoon session, the committee will discuss in-vitro/in-vivo relationship standards, and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/20/18-9/20/18

Meeting Details:

On Thursday, September 20, 2018, the PAC will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155). The PAC will meet to discuss the following Center for Drug Evaluation and Research products: INTUNIV LEXAPRO The FDA will provide general safety updates including updates on the following topics without vote by the committee: Overview of FAERS and lack of efficacy; Generic drug approval process; and discussion on trade versus generic drugs; exceptions; Summary of FDA completed review of pediatric safety issues and updated labeling changes for Exjade (deferasirox); Update labeling change for inhaled corticosteroid long-acting ß-2 agonists (ICS/LABAs); Safety labeling for gadolinium.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 9/12/18-9/12/18

Meeting Details:

The committee will receive information on the following two issues to follow up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination. Drug - > Uses Reviewed - >(alpha lipoic acid) Diabetic neuropathy and associated pain, acute liver toxicity from Amanitaspp. mushroom poisoning and other toxins, hepatitis C, cancer, cirrhosis, fibromyalgia, and muscle pain (coenzyme Q10) Mitochondrial disorders (creatine monohydrate) Mitochondrial disorders (pyridoxal 5 phosphate) Epilepsy and seizure disorders (choline chloride) Hepatic steatosis, supplementation in long term total parenteral nutrition, non-alcoholic fatty liver disease, fetal alcohol spectrum disorder, and atherosclerosis (quercetin dihydrate) Asthma, allergy, cancer prevention and treatment, and hypertension

 

       
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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