Meta-Analyses of Randomized Controlled Clinical Trials To Evaluate the Safety of Human Drugs or Biological Products; Draft Guidance for Industry; Availability

Samenvatting

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Meta- Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.'' This document, when finalized, will provide guidance to applicants submitting investigational new drug applications, new drug applications, biologics license applications, or supplemental applications on the use of meta- analyses of randomized controlled clinical trials (RCTs) to evaluate the safety of human drugs or biological products within the framework of regulatory decision-making.\1\ This draft guidance is also intended for FDA reviewers and for third-party entities that prepare or evaluate meta-analyses assessing the safety of drug products. Specifically, this guidance describes the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs. ---------------------------------------------------------------------------