FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies 

The U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. The draft guidance was developed by the Oncology Center of Excellence Project Equity in collaboration with the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity.