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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required

National Institutes of Health

The purpose of this funding opportunity announcement (FOA) 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.

Deadlines:

Letter of intent Due Date(s):
September 26, 2022 (Optional)

September 26, 2023 (Optional)

September 22, 2024 (Optional)
Application Due Date(s):
October 25, 2022,

October 24, 2023,

October 22, 2024

RFA-FD-23-001 Expiration Dates: October 23, 2024

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Medical - Translational

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type:

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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