New FDA Draft Guidance on Race and Ethnicity Data Collection Recommends Including Race and Ethnicity Information in Proposed Labeling

J.W. Schomisch
February 9, 2024 at 09:35 AM EST
Although the FDA’s new draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products — issued Jan. 30 — is little changed from guidance issued in 2016, the new draft guidance recommends that applicants include race and ethnicity information (using the categories described in the guidance) in their propose... Read More

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