Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans
FDA Law Blog
JANUARY 23, 2023
This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).
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