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

Funder: Food and Drug Administration

Due Dates: October 21, 2025 (Full application, new) | May 19, 2026 (Resubmission only) | September 21, 2026 (Letter of Intent, optional) | October 20, 2026 (Full application, new) | May 18, 2027 (Resubmission only) | September 20, 2027 (Letter of Intent, optional) | October 19, 2027 (Full application, new) | May 16, 2028 (Resubmission only / Final closing)

Funding Amounts: Up to $650,000/year (total costs) for 4 years; up to $900,000/year for innovative trial designs (with justification).

Summary: Supports clinical trials of orphan products to address unmet needs in rare diseases, aiming to increase approved treatments and impact rare disease drug development.

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

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