FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

FDA issued a draft guidance on Diversity Action Plans to improve enrollment of underrepresented populations in clinical studies, required under FDORA 2022. The plans aim to increase representation based on race, ethnicity, sex, and age, and must specify enrollment goals and strategies. Comments on the draft are due by September 26, 2024.


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FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

FDA issued a draft guidance on Diversity Action Plans to improve enrollment of underrepresented populations in clinical studies, required under FDORA 2022. The plans aim to increase representation based on race, ethnicity, sex, and age, and must specify enrollment goals and strategies. Comments on the draft are due by September 26, 2024.

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