FDA Orphan Products Grants — Natural History Studies (RFA-FD-25-017)
FDA Office of Orphan Products Development
Award
Prospective up to $400–600K/yr × 4 yrs; retrospective $150K/yr × 2 yrs
Deadline
Next receipt date Feb 8, 2028
Award type
Cash grant
Focus
Registries & biomarkers
Funds protocol-driven natural history studies that directly support product development.
Why it's in this index
Relevant to extending BTHS natural-history and registry data toward regulatory-grade endpoints — the gap between what the community has collected and what a submission needs.
Who can apply
Domestic and foreign applicants, academia and industry.
How to apply
Via Grants.gov / eRA Commons under RFA-FD-25-017. The Feb 10, 2026 receipt date has passed; the next is Feb 8, 2028.
Links & downloads
Related programs
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Last updated August 28, 2026 · Suggest an update to this entry