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U.S. Department of Health and Human Services

Drugs

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Public Meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions

Meeting information

On November 25, 2013, FDA is conducting a public meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions. This meeting will obtain input on scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate safety risks associated with the use of human drugs or biological products within the framework of regulatory decision making.
 
The purpose of the workshop is to initiate constructive discussion and information sharing among regulators, researchers, health-care providers, representatives from the pharmaceutical industry and health care organizations, and others from the general public, about the use of meta-analyses of randomized trials as a tool for safety assessment in the regulation of pharmaceutical products.
 
This website will be updated as meeting materials are developed.

Meeting Data
Date: 
November 25, 2013 
 
Time: 
8:00 a.m. to 4:45p.m.
 
Location:
FDA White Oak Campus 10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993 
 
 
Registration: 
To register for this meeting:
 
Registration closes on November 18, 2013.   

Meeting Materials - Agenda
 
 Federal Register Notice:
 
 
Adobe links to the recorded live Webcast from the meeting:
 
 
A video record of the meeting will be available at  https://collaboration.fda.gov/metaanalysis1113/  for 1 year."