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Forecast

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

The purpose of this opportunity 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.

FromFood and Drug Administration
Who can applyothers (see eligibility notes)
Eligibility notesHigher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher…
How muchAmount not stated
DeadlineNo deadline listed. Check the official posting.
CategoryConsumer Protection, Agriculture, Food and Nutrition
TypeGrant
Opportunity #FOR-FD-25-020
Assistance listing93.103
PostedFri, Jul 11, 2025

Heads-up: Forecast: not open yet. Dates and amounts are the agency's estimates.

Open the official posting

From the notice

The purpose of this opportunity 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.

We may have shortened this. The official posting is the record. We are not affiliated with the agency that published it.