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This document provides guidance to applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), 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.

This 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.