Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA

On June 28, 2024, the U.S. Food and Drug Administration (FDA) announced in the Federal Register the issuance of a draft guidance entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” Diversity Action Plans (DAPs) are mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was signed into……
By: King & Spalding