FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you're building solutions to reduce health disparities in device or drug access for underserved populations, FDA will fund your research—but not clinical trials.
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What this is
This FDA funding opportunity targets innovations that address health equity gaps in device or drug development, regulatory pathways, or implementation. The U01 mechanism supports collaborative research projects with substantial FDA involvement. Clinical trial costs are not fundable, so eligible work focuses on pre-clinical research, real-world evidence generation, health systems integration, or regulatory science. Award amounts and specific eligible applicant types are not detailed in the source material.
Who can apply
Eligible applicants likely include academic institutions, non-profits, small businesses, and research organizations (standard NIH/FDA eligibility), though specific applicant type restrictions are not provided in this source. Projects must address health equity without conducting clinical trials.
Topics: health equity · fda funding · medical device · disparities · regulatory science · u01 grant
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.