USFDA announces funding opportunity for Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases. Orphan Product Grant FAQs . Read More..

USFDA has announced funding opportunity for FDA Orphan Products Clinical Trials Grant Program. The deadline for submission of applications is October 24, 2023. The grants are available to any foreign or domestic entity. The grants are provided for clinical trials of products for evaluating efficacy and/or safety in support of a new indication or change in labeling of products to address unmet needs in rare diseases. Grants are provided in all phases of product development (Phase 1, 2 and/or 3). Grant amount shall be $650,000 per year in total costs up to a maximum of four years of support. There is also a provision for additional funding request not exceeding $250,000 per year.

Orphan Product Grants FAQs

Orphan Products Grants Program

Applying for grant