If your email program has trouble displaying this email, view as a webpage.

FDA Office of Minority Health and Health Equity

January 29, 2024

FDA publishes draft guidance on collecting demographic data for clinical trials and clinical studies

Today the Food and Drug Administration is announcing the availability of draft guidance for industry titled, “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.”

The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and clinical studies for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled "Collection of Race and Ethnicity Data in Clinical Trials" issued on October 26, 2016.

Submit either electronic or written comments on the draft guidance by April 29, 2024 to ensure the agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity
"Creating a world where health equity is a reality for all."
www.fda.gov/HealthEquity