- Docket Number:
- Issued by:
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthOffice of the Commissioner, Office of Minority Health and Health Equity
The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.
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:
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-2021-D-0789.