FDA updates 2016 guidance on the collection of race and ethnicity data

Lexology February 17, 2024
Hogan Lovells

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document entitled, “Collection of Race and Ethnicity Data in Clinical Trials,” which provides recommendations on the standardized collection of race and ethnicity data. Although we continue to await FDA guidance on diversity action plans, this latest guidance suggests the agency is laying the groundwork for additional guidance promoting clinical trial diversity. FDA is seeking comments on the draft guidance through April 29, 2024.

FDA originally published final guidance on the collection of race and ethnicity data in clinical trials in 2016, in response to the Office of Management and Budget (OMB) Statistical Policy Directive 15,...

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