FDA Issues Draft Guide To Spur Pooled Clinical Trials To Weigh Drug Safety

November 08, 2018
FDA issued draft guidance Tuesday (Nov. 6) that it hopes will help encourage drug and biological product sponsors to more often pool together clinical studies so they and the agency can use the information to better evaluate product safety. Combining safety data from different randomized controlled trials and conducting proper evaluation -- or meta-analysis -- of the pooled information can provide a more precise picture of a product's safety and influence regulatory decisions, FDA Commissioner Scott Gottlieb says. The draft...

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