Public Meeting on Meta-Analyses of Randomized Controlled Clinical Trials for the Evaluation of Risk to Support Regulatory Decisions
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.
November 25, 2013
8:00 a.m. to 4:45p.m.
FDA White Oak Campus 10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993
To register for this meeting:
All attendees: http://www.surveymonkey.com/s/QRKMGNY
Registration closes on November 18, 2013.
Federal Register Notice:
Adobe links to the recorded live Webcast from the meeting:
Before 1st Break: https://collaboration.fda.gov/p64hd2tyrid/
After 1st Break: https://collaboration.fda.gov/p28gsl0p6iu/
After Lunch: https://collaboration.fda.gov/p89ehi578hd/
After Final Break: https://collaboration.fda.gov/p7jixrm431a/
A video record of the meeting will be available at https://collaboration.fda.gov/metaanalysis1113/ for 1 year."