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# Draft Guide on Drug Safety Meta-Analyses
- URL: https://www.fdaweb.com/draft-guide-on-drug-safety-meta-analyses/
- Published: 2018-11-07T12:00:00.000Z
- Updated: 2026-09-15T00:43:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142763

*Federal Register* notice: FDA has made available a draft guidance entitled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.” The document describes the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the safety of drugs. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-11-07/pdf/2018-24316.pdf?ref=fdaweb.com).