Lexology July 8, 2024
Key Takeaways:
On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving drugs, devices and biological products. This guidance was issued pursuant to the Food and Drug Omnibus Reform Act of 2022, and it replaces the FDA’s prior guidance for diversity plans. Compliance will be mandatory for clinical trials where enrollment starts 180 days after the final guidance is published.
The purpose of requiring DAPs is to increase the enrollment of underrepresented populations in clinical studies, thereby improving the generalizability and robustness of clinical data. Specifically, DAPs will be focused on recruiting study participants from populations that...
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