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GrantFDA Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RFA-FD-25-020)
Atlas Opportunity Score91/100
FundingUp to $650,000 in total costs per year for up to 4 years. With justified innovative or efficient trial approaches, up to an additional $250,000 in total costs per year may be requested, for a maximum of $900,000 per year. Cost sharing is not required. FDA estimates approximately $17 million in annual clinical trial grant support, subject to availability of funds.
DeadlineOctober 20, 2026 at 11:59 PM Eastern Time for new applications; optional letter of intent due September 21, 2026.
Required next actionAdvance only if a genuine qualifying orphan-product clinical trial, product access or supply, qualified PI and clinical team, trial sites and patient access, active registrations, and required human-subjects and FDA regulatory infrastructure can be independently substantiated, including an active IND or IDE where required. Otherwise route as a partner-led opportunity.
Current statusActiveSource verificationOctober 3, 2026
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How Atlas Scores Fit
Useful enough to guide action, structured enough to scale.
Strategic Alignment
How directly the organization's goals and use case match the funder's priorities.
Funding Potential
Available dollars, allowable uses, match burden and the amount that can realistically support the project.
Actionability
Deadline, documentation burden, readiness and the practical work required to submit a strong application.
A High Score Is the Beginning
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