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# FDA Late with Diversity Plan Guidance
- URL: https://www.fdaweb.com/fda-late-with-diversity-plan-guidance/
- Published: 2024-02-15T12:00:00.000Z
- Updated: 2026-09-14T14:23:09.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5156377

FDA is several weeks late in issuing a guidance on how and when drug and medical device companies must submit diversity action plans for clinical trial research, according to a Regulatory Affairs Professionals Society (RAPS) *Regulatory Focus* online [post](https://www.raps.org/News-and-Articles/News-Articles/2024/2/FDA-misses-congressional-deadline-to-update-clinic?ref=fdaweb.com). The December 2022 Food and Drug Omnibus Reform Act requires manufacturers to submit diversity plans to FDA outlining how they plan to enroll a diverse group of trial participants for Phase 3 and other pivotal trials. The law required the agency to issue or update guidance on diversity plan content within one year.

The post says FDA Oncology Center of Excellence executive **Lola Fashoyin-Aje** reported that the agency is “working very hard” to complete the draft guidance on diversity plans.

It says that Representative **Anna Eshoo** (D-CA) told a Friends of Cancer Research meeting on trial diversity that she would “hold FDA accountable to ensure it holds up its end of the law because patients and their families should not have to wait any longer to be part of life-changing clinical trials.”