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 (FDA)

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

Summary: Supports clinical trials of orphan products for rare diseases to address unmet medical needs and facilitate new indications or labeling changes.

Key Information: Clinical trials (all phases) are required; foreign and domestic organizations are eligible; innovative designs may request additional funds.

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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