STAT April 19, 2024
The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part of the Consolidated Appropriations Act of 2023, will encourage greater diversity in clinical trials and help ensure new medications and treatments are developed with more representative populations in mind. But FDORA represents a paradigm shift for life sciences companies in the way individuals will be identified for clinical trials and enrolled in them, requiring companies to look closely at and rethink their current trial strategies.
FDORA will require trial sponsors to include diversity action plans for Phase 3 and other pivotal studies of new drugs and devices to contribute...
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