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The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more

7/3/2024 / Clinical Trials , Diversity , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices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The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more

4/21/2022 / Clinical Trials , Diversification Requirements , Diversity , Draft Guidance , Food and Drug Administration (FDA) , IRB , Medical Devices , Pharmaceutical Industry , Reporting Requirements

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

12/29/2021 / Clinical Trials , Compliance , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Popular , Regulatory Oversight , Technology

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