Lexology August 21, 2023
Continuing the trend over the past few years to promote diversity in clinical trials, the U.S. Food and Drug Administration (FDA) has published new draft guidance on “Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products,” which describes strategies that clinical trial sponsors can utilize post-approval to enhance safety and efficacy data for populations that may have been underrepresented in premarket studies. Below we summarize FDA’s latest recommendations regarding enhancing patient diversity in clinical trials, which spotlight the need for sponsors to prepare diversity plans that comply with both FDA guidance and the new legislative requirements of the Food & Drug Omnibus Reform Act (FDORA).
FDA regulations require clinical trial sponsors to present...
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