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

<p><span style="color: rgb(51, 51, 51);">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.&nbsp;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.</span></p>

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Solicitation Details

Issuing agencyFood and Drug Administration
CountryUnited States
CategoryOther
Estimated value$900,000
NAICS93.103
PublishedJuly 11, 2025
Procurement stageRequest for Proposal (RFP)
Response dueMay 16, 2028
StatusOpen — accepting responses
Official sourceView original notice
Last verifiedAugust 12, 2026

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

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