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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

Funds foreign and domestic entities running rare-disease clinical trials through FDA orphan products research grants.

The Food and Drug Administration administers this grant through the Office of Orphan Products Development rare disease research grant programs. The R01 notice funds clinical trials of orphan products that evaluate efficacy or safety for a new indication or labeling change addressing unmet needs in rare diseases or conditions.

The source states that foreign or domestic public or private for-profit

BiotechMedtech

Each grant below is a distinct funding opportunity with its own eligibility, scope, and deliverables.

Last verified: 23 Jun 2026Source: www.fda.gov