FDA Guidance – Clinical Trial Diversity Action Plans – Client Update – January 2025
Last July, the FDA issued draft guidance on Diversity Action Plans, replacing its 2022 draft guidance (click here for the full draft guidance). The stated purpose of Diversity Action Plans is to increase enrollment of underrepresented populations in clinical trials of drugs and medical devices, in order to improve the generalizability of study results and to detect clinically important differences across populations. Final guidance is expected to be published later this year, and the requirement to submit Diversity Action Plans as part of a sponsor’s clinical trial package is expected to be implemented from early 2026. Clinical study sponsors should therefore begin preparing accordingly.
In this Client Update, we review the FDA’s draft guidance on Diversity Action Plans and its implications for Israeli pharma and medical device companies conducting clinical trials.
We advise clinical trial sponsors to monitor developments in this area, and work to ensure their relevant clinical trial submissions meet these new requirements.
The information provided in this client update is for general informational purposes only and should not be construed as legal advice or a substitute for professional legal counsel.
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