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# Underrepresented Population Data Guidance
- URL: https://www.fdaweb.com/underrepresented-population-data-guidance/
- Published: 2023-08-10T12:00:00.000Z
- Updated: 2026-09-14T18:49:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155072

FDA has published a draft guidance, *Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products*, describing FDA’s requirements on and providing recommendations for obtaining safety and effectiveness information on drugs, when appropriate, in the postmarketing setting in historically underrepresented patient populations in clinical trials. The [document](https://www.fda.gov/media/170899/download?ref=fdaweb.com) specifically discusses:

- mechanisms by which FDA can require or request information on safety and effectiveness be collected in the postmarketing setting;
- design and statistical considerations for subpopulation analyses; and
- postmarketing approaches to obtain information on the benefit/risk profile in underrepresented clinical trial populations.