FDA review of clinical trial best practices

The Commissioner of Food and Drugs shall— (1) aggregate information on the accumulated experience of sponsors of drugs that develop and execute clinical trial diversity plans during drug development; (2) include in such aggregated information an analysis from the perspectives of the Food and Drug Administration and such sponsors of which actions worked or which did not work to enhance clinical trial diversity; (3) not later than September 30, 2027, convene a public meeting, including representatives from the regulated industry and patient organizations, to discuss findings and recommendations for specific actions that have led to measurable improvements in the representation of racial and ethnic populations in clinical research; and (4) not later than September 30, 2028, update the guidance of the Food and Drug Administration titled Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs to align such guidance with findings and recommendations that were discussed at the meeting under paragraph (3).