> ## Content Index
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# Data on Under-Represented Patients Guide
- URL: https://www.fdaweb.com/data-on-under-represented-patients-guide/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:49:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155085

*Federal Register* notice: FDA is making available a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.” The document describes FDA requirements and provides recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting affecting historically under-represented patient populations in clinical trials. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-08-11/pdf/2023-17267.pdf?ref=fdaweb.com).