FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

BY LAURA DIANGELO, MPH

The FDA has just unveiled its long-awaited draft guidance on diversity action plans. The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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