Postmarketing Approaches To Obtain Data on Under-Represented Populations in Clinical Trials; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials." The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under- represented patient populations in clinical trials.
Abstract as published in the Federal Register.
See the structure of SPEQ’s reviewed analysis
Explorer members can open three bounded, human-reviewed previews each month. Full relationships, analysis, and implementation implications remain protected.
Sign in free to preview →The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.