Grant Funding Opportunity for Rare Diseases Research – Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds 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.

Receipt dates are the following: October 25, 2022; October 24, 2023; October 22, 2024

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

More information is available here.