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 and nonprofit entities may apply, while federal agencies may not. The captured facts provide current receipt dates on October 20, 2026 and October 19, 2027 for new applications and resubmissions. The source also describes approximately $17 million per fiscal year for the broader clinical trials grants program, including approximately $5 million for new awards, but it does not state a per-applicant award cap.
Clinical trials evaluating efficacy or safety of medical products for new indications or labeling changes addressing unmet needs in rare diseases.
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