Updated FDA Draft Guidance Instructs Sponsors on Content, Format, Timing, and Procedures for Submitting Diversity Action Plans for Clinical Studies

Lexology July 9, 2024
Troutman Pepper

Back in 2022, we wrote about U.S. Food and Drug Administration’s (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” On June 24, FDA replaced that draft guidance with a new one, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance).[1] The Draft Guidance, which tracks new requirements under the Food and Drug Omnibus Reform Act (FDORA),[2] provides more detail on the applicability, elements, and timing of diversity action plans (DAPs) and expands their scope to cover age and sex in addition to race and ethnicity.[3] FDA also recognizes that other factors such as geographic location, gender identity, sexual orientation, socioeconomic status,...

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