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# Plan Now to Adopt FDA Trial Diversity Guide: Lawyers
- URL: https://www.fdaweb.com/plan-now-to-adopt-fda-trial-diversity-guide-lawyers/
- Published: 2024-07-08T12:00:00.000Z
- Updated: 2026-09-14T14:34:39.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5157291

Although FDA says that compliance with its new Diversity Action Plan (DAP) initiative outlined in a recent [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies?ref=fdaweb.com) won’t take effect until 180 days after the future final guidance is published, drug and medical device sponsors should start planning how they will comply with the significant new requirements. That’s the advice of five Hogan Lovells attorneys writing in an online [post](https://www.lexology.com/library/detail.aspx?g=6635f28f-ec4c-45b7-9f63-17acf2608d7d&utm%5Fsource=Lexology+Daily+Newsfeed&utm%5Fmedium=HTML+email+-+Body+-+General+section&utm%5Fcampaign=Lexology+subscriber+daily+feed&utm%5Fcontent=Lexology+Daily+Newsfeed+2024-07-02&utm%5Fterm=) analyzing the draft.

“It is important to note that, when finalized, this guidance will create binding requirements on study sponsors,” the attorneys write. “This is unlike most FDA guidance documents that just provide the agency’s recommendations.”

The post summarizes the draft guidance’s recommendations and requirements on:

- which drug and device sponsors should submit DAPs;
- the types of content that should be included in a DAP, including the enrollment goals, the rationale for those goals, and the metrics to meet them;
- the timeline and procedures for submitting a DAP to FDA;
- how diversity goals should be considered when conducting multinational studies; and
- the circumstances under which the agency may grant a DAP waiver.

“We recommend that sponsors consider engaging with the agency even before the finalization of the draft guidance to consider which modifications to their clinical development infrastructure will be required to meet DAP requirements,” the attorneys conclude.

FDA will receive comments on the draft until 9/26.