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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    
Materials:
   
       

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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 OptionsCirculatory System Devices Panel - - Sponsor: Impulse Dynamics, Inc.

Meeting Date: 12/4/18-12/5/18

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Meeting Details:

On December 4, 2018, the committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind device is indicated to provide cardiac contractility modulation for class III heart failure patients who are not responding to optimal medical therapy. On December 5, 2018, the committee will discuss and make recommendations regarding issues relating to the emergence of medical devices, which aim to treat hypertension. Currently, clinical studies to evaluate the safety and effectiveness of these devices are progressing. FDA requests panel input regarding the potential indications and labeling for devices intended to treat hypertension and optimal study designs needed to evaluate the potential benefits and risks while considering issues such as medication compliance, patient perspective, and appropriate study controls.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic &Analgesic with DSRM AdComm

Meeting Date: 12/17/18-12/18/18

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Meeting Details:

The committees will provide input and advice on strategies to increase the availability of naloxone products intended for use in the community. The committees will be asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the committees will also be asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients.

 

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

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

On November 15, 2018, the Committee will discuss and make recommendations on the topic “Connected and Empowered Patients: e-Platforms Potentially Expanding the Definition of Scientific Evidence.” The recommendations will address how FDA can leverage patient-driven platforms, such as social media and registries, to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. Social media and other web platform enablers are facilitating the growth of virtual patient communities. Increasingly, patients and health care consumers are using these platforms to share their health experiences and seek information from other patients and consumers, rather than their health care providers alone. Novel approaches and methodologies are being used to tap into some of these platforms as potentially rich sources of patient-generated health data, which could be used as relevant and reliable real-world evidence. This meeting will help advance FDA’s objective to assure the needs, experiences, and perspectives of patients are included as part of FDA’s deliberations involving the regulation of medical devices and their use by patients. For this meeting, FDA is seeking input from the Committee and the public on whether and how FDA can harness the emerging potential of these patient platforms to better engage patients and consumers as empowered partners in the work of protecting public health and promoting responsible innovation. In addition, FDA is seeking recommendations from the Committee on ways to leverage these platforms to disseminate as well as potentially collect and evaluate health information to and from patients and consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic & Analgesic Drug Products AdComm

Meeting Date: 11/15/18-11/15/18

Meeting Details:

The committee will discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The committee will be asked to comment on the trial design and endpoints of these studies and how to determine the clinical relevance of the results.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic & Analgesic with DSRM AdComm - Sponsor: SpecGX Inc.

Meeting Date: 11/14/18-11/14/18

Meeting Details:

The committees will discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the 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 OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Sage Therapeutics

Meeting Date: 11/2/18-11/2/18

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 211371, brexanolone 5 mg/mL intravenous injection, submitted by Sage Therapeutics, for the proposed indication of postpartum depression.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSRM AdComm - Sponsor: Alkermes Inc.

Meeting Date: 11/1/18-11/1/18

Meeting Details:

The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 210417 for buprenorphine and samidorphan sublingual tablets, submitted by Alkermes, Inc., for adjunctive treatment of major depressive disorder.

 

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

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

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    
Materials:
   
       

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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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