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AAMC Center for Health Justice Submits Letter to FDA on Race and Ethnicity in Clinical Trials

May 3, 2024

The AAMC and the AAMC Center for Health Justice submitted a letter to the Food and Drug Administration (FDA) on May 3 in response to the agency's draft guidance for a standardized approach for collecting race and ethnicity data in clinical trials.

The FDA's draft guidance cites the White House Office of Management and Budget (OMB)'s new race and ethnicity data standards, which the Center also commented on. In its letter to the FDA, the Center highlighted key areas in the draft guidance that are consistent with the new updates to SPD 15, as well as areas that should be reevaluated. The Center also recommended robust collaboration with other agencies implementing the revisions to the revised OMB standards. 

Read the letter