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Program

Orphan Products Natural History Studies Grants Program

Supports grants for protocol driven natural history studies that fill knowledge gaps and enable clinical trials in rare diseases.

FDA Office of Orphan Products DevelopmentUnited StatesGrant

The Orphan Products Natural History Studies Grants Program is a sub-program of the FDA Office of Orphan Products Development's broader orphan-products portfolio. Established in 2016, it funds protocol-driven natural history studies that close knowledge gaps, support clinical trials, and advance rare-disease medical product development.

The program is on a biennial rhythm. The most recent receipt …

BiotechMedtech

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

Last verified: 29 May 2026Source: www.fda.gov