FDA Updates Guidance on Clinical Trial Diversity Action Plans
Summary
The FDA has finalized guidance requiring sponsors to submit Diversity Action Plans (DAPs) for all Phase 3 clinical trials included in NDA and BLA applications. The final guidance expands demographic data collection requirements beyond the draft version, now mandating stratified enrollment targets across race, ethnicity, sex, and age. Plans must be submitted no later than Phase 2 end-of-study meetings. The guidance establishes a 60-day FDA review timeline for submitted DAPs and introduces a "comply or explain" framework where sponsors who cannot meet targets must provide written justification.
What changed
Key changes from draft to final guidance:
Scope expanded: Now covers all Phase 3 trials in NDA/BLA submissions, not just "pivotal" trials as in the draft.
Enrollment targets added: Final version requires specific numerical enrollment targets stratified by race, ethnicity, sex, and age group. Draft only required "goals."
Submission timing clarified: DAPs must be submitted at Phase 2 end-of-study meeting (draft said "prior to Phase 3").
FDA review timeline: New 60-day review window for DAPs with written feedback. Not in draft.
Comply or explain: New framework allowing sponsors to deviate from targets with written justification. Draft had no deviation mechanism.
Removed: Draft language suggesting voluntary compliance has been replaced with mandatory framing tied to application completeness.
Why it matters
Pharma sponsors must redesign trial recruitment : Every Phase 3 trial in an NDA/BLA submission now requires a Diversity Action Plan with specific numerical targets - not just aspirational goals.
60-day FDA review creates new timeline risk : DAP feedback adds a new dependency to the regulatory submission timeline. Sponsors who submit late risk delaying their NDA/BLA.
CROs need updated SOPs immediately : Contract research organizations running Phase 3 trials must build DAP processes before April 2026 or risk non-compliance for their sponsor clients.
What to do next
- Review the final guidance and compare to your current enrollment practices
- Assess whether your active Phase 3 trials will need DAPs before April 2026
- Update SOPs for trial design to include diversity action plan development
- Brief clinical operations teams on the 60-day FDA review timeline
Detected change
Source content
Diversity Action Plans to Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies
Guidance for Industry
This guidance finalizes the draft guidance of the same title issued in April 2024. This guidance describes FDA's recommendations for sponsors regarding the development and submission of diversity action plans (DAPs) for certain clinical studies of drugs and devices.
I. Introduction
The FDA Omnibus Reform Act of 2022 (FDORA) added section 505(z) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 520(h) to the FD&C Act, which require the submission of DAPs for certain clinical studies intended to support applications for drugs and devices.
II. Background
Clinical trial populations have historically lacked diversity with respect to race, ethnicity, sex, and age. This underrepresentation limits the generalizability of clinical trial results and may obscure differences in how medical products work across diverse groups.
III. Recommendations
A. Diversity Action Plan Requirements
Sponsors must submit a Diversity Action Plan for all Phase 3 clinical trials included in NDA and BLA applications. Plans must include:
- Specific numerical enrollment targets stratified by race, ethnicity, sex, and age group
- Rationale based on disease epidemiology data
- Planned enrollment strategies to achieve targets
- A description of engagement efforts with underrepresented communities
B. Enrollment Targets
Targets should reflect the known epidemiology of the condition under study in the United States. FDA recommends using data from peer-reviewed literature, registries, and real-world data sources.
C. Submission Timing
DAPs must be submitted no later than the Phase 2 end-of-study meeting. FDA will provide written feedback within 60 calendar days of receipt.
IV. Sponsor Responsibilities
Sponsors who determine that proposed enrollment targets are not feasible must provide a written justification explaining the basis for deviation and alternative measures taken to improve diversity in enrollment.
Source
Food and Drug Administration
Classification
Who this affects
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