On April 30, 2024, the FDA issued a draft guidance outlining requirements for diversity action plans (DAPs) in clinical trials, reflecting the FDA’s push for broader representation across studies and offering sponsors clarity on expectations under the 2022 FDORA law.
Robert Romanchuk, our Director of Regulatory Affairs and IRB Chair, uses this article to walk through the FDA’s guidance and what it means for trial design, recruitment, and regulatory readiness. Read it now to learn:
- What trials require a diversity action plan under FDORA
- What information must be included in a DAP
- Key takeaways from FDA’s guidance and how Univo IRB can help with clinical trial diversity
