Opportunity to review and provide comment on the draft guidance "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products,"issued by FD A's Onocology Center of Excellence
U.S. Department of Health and Human Services
U.S. Food and Drug Administration
October 10, 2023
Food and Drug Administration is soliciting comments on the draft guidance “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.” The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under-represented patient populations in clinical trials. This draft guidance, when finalized, will represent current thinking of the FDA on this topic. FDA welcomes input from Tribes and encouraged the submission of comments concerning any potential implications this draft guidance may have for Tribal communities. Comments are due by October 10. The Dear Tribal Leader Letter is here, and more information can be found here.