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Clinical Trial Diversity Advances in Regulatory Agenda

April 20, 2022


FDA recently issued a new guidance on how to make clinical research more inclusive, building on earlier, broader advisories on the topic. At the same time, Congress is looking to advance legislation promoting clinical trial diversity in pre- and post-market studies, while the latest revision to drug user fee programs includes provisions for advancing clinical trial diversity in sponsors’ R&D programs. These initiatives fit the Biden administration’s broader goal of addressing racial and ethnic health care disparities through a range of public research and coverage programs.

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