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Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

US · MD Food and Drug Administration (FDA), Department of Health and Human Services (HHS) grant open #RFA-FD-25-020
Response due May 16, 2028 · 00:00 UTC

Summary

The Food and Drug Administration (FDA) is reissuing funding opportunity RFA-FD-23-001 as RFA-FD-25-020 to solicit R01 grant applications for clinical studies of orphan products that address unmet medical needs in rare (orphan) diseases. Applicants must propose clinical trials as a required component of their research. The opportunity is open from July 2025 through May 2028, indicating a multi-cycle, long-running funding program. This is a federal grant posted on Grants.gov and is not a traditional procurement contract.

What they want

Applicants must design and conduct clinical studies (clinical trials required) involving orphan products — drugs, biologics, or medical devices designated for rare diseases — that address documented unmet medical needs. The research mechanism is R01 (Research Project Grant). Studies must focus on populations with rare/orphan diseases and generate clinically meaningful evidence on orphan product safety and/or efficacy. This is a reissue of the prior funding opportunity RFA-FD-23-001, updated as RFA-FD-25-020.
Technical requirements
  • Clinical trial must be a required component of the proposed research (not optional)
  • Research mechanism: R01 (Research Project Grant)
  • Studies must involve orphan-designated products (drugs, biologics, or devices for rare diseases)
  • Must address documented unmet medical needs of rare disease populations

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

  • Extremely long open window (nearly 3 years, July 2025–May 2028) may indicate rolling submission cycles rather than competitive single-award structure — scope of competition per cycle is unclear from synopsis alone
  • Minimal detail provided in the synopsis; full program requirements, budget caps, and eligibility criteria are not disclosed in this record

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Reissue of RFA-FD-23-001- Clinical Studies…
Due May 16
Onboard ↗