FDA's Diversity Action Plan Guidance Heads to White House for Final Review.
- Ariel Rieumont
- Apr 24, 2024
- 1 min read
Exciting news in healthcare and regulatory affairs as the FDA's Diversity Action Plan (DAP) guidance moves to the White House Office of Information and Regulatory Affairs (OIRA) for final review. This marks a significant step toward promoting diversity and inclusivity in clinical trials.
Under new legislation, sponsors of certain trials will be required to develop and submit a DAP, outlining plans to ensure study populations reflect the diversity of the U.S. This addresses historical underrepresentation, aiming for more equitable healthcare.
The lack of diversity in trials has long been an issue, leading to biased results. The FDA's proactive approach, with DAPs focusing on key diversity areas, including race, ethnicity, age, gender, and socioeconomic status, aims to enhance recruitment and retention of underrepresented groups.
This move demonstrates the FDA's commitment to health equity and safe, effective medical products for all. Once approved, sponsors can utilize the guidance to develop comprehensive DAPs, resulting in more representative trials and improved healthcare outcomes for diverse populations.
The FDA's Diversity Action Plan guidance heading to the White House is a significant milestone in the journey toward greater diversity and inclusivity in clinical research, promising a more equitable healthcare landscape for all Americans.
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