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

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.

Canonical page: https://grantsonar.com/grants/opportunity/reissue-of-rfa-fd-23-001-clinical-studies-of-orphan-products-addressing--ff3b6d92-9d6b-4cac-b327-d2a5e9d5857e
Source: grants_gov
Source ID: 360008
Last confirmed Oct 13, 2026 · Grants.gov
Deadline: May 16, 2028
Award size: not disclosed

## Answer-first Q&A

### Who is eligible for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) eligibility includes eligible applicants named in the notice. Geographic eligibility is national or notice-specific geography; applicants should confirm the source notice before applying.

### What is the deadline for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) has a listed deadline of May 16, 2028. Grant deadlines can change, so verify the current date with Food and Drug Administration before submitting.

### How much funding is available for Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)?

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) lists an award size of not disclosed. Award ranges and total program funding are reported from the source metadata when available.

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

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) is funded by Food and Drug Administration. GrantSonar tracks the notice with source ID 360008 from grants_gov.