Lexology August 19, 2024
Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and Drug Omnibus Reform Act (FDORA) provisions of the Consolidated Appropriations Act of 2023, requiring sponsors of certain clinical studies of drugs, biological products, and medical devices to submit Diversity Action Plans to the FDA (FDCA Sections 505(z) and 520(g)(9)).
FDA’s recent publication of the draft guidance document on Diversity Action Plans (Draft Guidance) addresses Congress’s requirement for FDA to publish guidance describing Diversity Action Plan development, content, submission, and waiver practices. This guidance, when finalized, will begin the countdown to these requirements coming into effect for clinical trial sponsors,...
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