Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans
FDA Law Blog
JULY 9, 2024
For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). . § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). For devices, the requirement is a bit more nuanced.
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