Issue Date: August 10, 2023
Issued by: Oncology Center of Excellence
Topic(s): Clinical – Medical
Status: Draft
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.” The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when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.
Download the Guidance Document
