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GUIDANCE DOCUMENT

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft Guidance for Industry June 2024

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-0789
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Office of the Commissioner, Office of Minority Health and Health Equity
Office of the Commissioner, Office of Women's Health

This draft guidance describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan.  It replaces the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials,” published April 14, 2022

FDA is issuing this guidance as mandated under section 3602 of FDORA, which requires that FDA update or issue guidance relating to the format and content of diversity action plans required by sections 505(z) and 520(g) of the FD&C Act (21 U.S.C. 355(z) and 360j(g) as amended by section 3601 of FDORA.


Submit Comments

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:

Dockets Management
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.

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