Draft Guidance for Industry
JUNE 2024
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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:
Issued by:
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This draft guidance describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is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It replaces the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials,” published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.
Additional Resources: