Announcement of FDA Office of Orphan Products Grant Funding Opportunity

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal year (FY) 2025 to support clinical trials for rare diseases and conditions. The purpose of this funding opportunity announcement is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Deadline for submission: October 22, 2024

Additional Information and Contact: Katherine Needleman, Director, Orphan Products Grants Program. E-mail:

Check out more details about the application submission process: OOPD Website