Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans
FDA Law Blog
JANUARY 23, 2023
More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).
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