Clinical Research: Phase 1 - Phase 4
FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All
On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions...