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

Food and Drug Administration · United States government procurement

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$900,000
Est. Value
May 16, 2028
Response Due
Active
Status

Opportunity Overview

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. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

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Solicitation Details

Issuing agencyFood and Drug Administration
CountryUnited States
CategoryOther
Estimated value$900,000
PublishedJuly 11, 2025
Procurement stageRequest for Proposal (RFP)
Response dueMay 16, 2028
StatusOpen — accepting responses
Official sourceView original notice
Last verifiedOctober 06, 2026

Source: U.S. Government (Simpler.Grants.gov) — public domain. Not affiliated with or endorsed by the United States Government.

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