Angelique Salib

Bass, Berry & Sims PLC

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FDA's Diversity Action Plans for Clinical Trials: Key Deadlines and Compliance Requirements

The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more

7/3/2024  /  Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices

FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know

The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

4/21/2022  /  Clinical Trials , Diversification Requirements , Diversity , Draft Guidance , Food and Drug Administration (FDA) , IRB , Medical Devices , Pharmaceutical Industry , Reporting Requirements
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