5 Specifications That The FDA's Diversity Plan Needs To Include

By Maimah Karmo

In April 2022, the FDA made available for public comment its Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials guidance for industry. The 12-page draft guidance document offers information that represents the FDA’s suggestions and recommendations for sponsors currently developing medical products on an approach for developing their own race and ethnicity diversity plans. The stated goal of these plans is to enroll proper representative numbers from underrepresented racial and ethnic groups in U.S. clinical trials.