FDA In Brief > FDA in Brief: FDA advances new guidelines for analysis of clinical trials evaluating safety of drug and biologic products

FDA In Brief > FDA in Brief: FDA advances new guidelines for analysis of clinical trials evaluating safety of drug and biologic products

Today, the U.S. Food and Drug Administration (FDA) made available the draft guidance titled, “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products,” for public comments. The FDA is issuing this draft to provide guidance to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental application on the appropriate use of prospective meta-analyses to assess a product risk. This draft guidance specifically focuses on meta-analyses for evaluating safety data from randomized, controlled trials. 

Evaluating the safety of a regulated drug product is a fundamental responsibility of the FDA. Meta-analyses for safety presents a unique opportunity to provide a precise rate of uncommon serious adverse events by combining information from multiple studies. Committed to transparency regarding evidentiary standards, the guidance also describes the criteria the FDA applies when evaluating the strength of evidence provided by a meta-analysis. 

For additional information, refer to the FDA In Brief Notice and  Federal Register Notice