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RFA-FD-25-020Food and Drug AdministrationR01

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

Deadline
Award ceiling
$900,000
Awards
Not stated
Posted
Jul 11, 2025

Official announcement on the NIH Guide · opens the funder's page. Always confirm dates there.

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Summary

The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions…

Related announcements1

Other open R01 announcements on related subjects, with at least two weeks to go.

Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)

RFA-FD-25-017Food and Drug Administration4 review criteria on fileagency framework

$600k

The full announcement, free with an account

  • The full announcement text, not just the first two sentences
  • All 4 standing review criteria Food and Drug Administration applies to this kind of proposal (its standard framework, not criteria written for this announcement)

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  • The eligibility check against your profile: career stage, institution type, and the windows that close before the deadline does
  • Funded precedents: what similar NIH projects received, from the award records in NIH RePORTER
  • A Reviewer Scorecard of your draft against these criteria
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Source record: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-020.htmlVia the NIH Guide. Last checked against the source . Always confirm dates with the funder.