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# Diversity Action Plan Submissions Up
- URL: https://www.fdaweb.com/diversity-action-plan-submissions-up/
- Published: 2025-01-08T12:00:00.000Z
- Updated: 2026-09-14T14:50:27.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5158449

An FDA summary report on clinical study diversity action plans for FY 2023 and FY 2024 shows that submission of the action plans to the agency is going up, even though such submissions are not yet required. The [report](https://www.fda.gov/media/184768/download?attachment?source=email&ref=fdaweb.com) shows that CDER received 124 plans in FY 2023 and 161 in FY 2024\. The comparable figures for CBER were 9 and 21, and for CDRH they were 6 and 24.

The agency says it is working to finalize a 6/2024 draft guidance that will mandate the submission of diversity action plans for certain studies for which enrollment commences after 180 days from the publication of the final guidance.

Diversity action plans are to include the sponsor’s goals for enrollment in the clinical study, the sponsor’s rationale for such goals, and an explanation of how the sponsor intends to meet the goals, FDA says.

“Enhancing diversity within clinical studies not only facilitates applicability of results across a broad spectrum of patient populations but also enhances understanding of the disease or medical product under study,” the report concludes, “thus providing valuable insights to inform the safe and effective use of the medical product among patients.”