Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of Diversity Action Plans required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FDORA. This guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type. In addition, this draft guidance describes the criteria and process by which FDA will evaluate sponsors' requests for waivers from the FD&C Act. Because FDA is required by statute to specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as this draft guidance specifies the form and manner for submission of Diversity Action Plans, when this guidance is finalized, it will have binding effect.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.