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FDA’s Diversity Action Plans for Clinical Trials: Key Deadlines and Compliance Requirements

The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance). This Draft Guidance replaces and rewrites the draft guidance issued in April of 2022 (2022 Diversity Plan Draft Guidance), which only recommended the voluntary submission of diversity plans to enroll representative numbers of participants from…
By: Bass, Berry & Sims PLC
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