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GUIDANCE DOCUMENT

Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products November 2018

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-3710
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.”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evaluate the safety of human drugs or biological products within the framework of regulatory decision-making.[1] This draft guidance is also intended for FDA reviewers and for third-party entities that prepare or evaluate meta-analyses assessing the safety of drug products.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.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3710.