Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)
Key Facts
Status: Open
Posted date: July 11, 2025
Opportunity ID: 359987
Opportunity number: FOR-FD-25-020
Opportunity category: Discretionary
Agency name: Food and Drug Administration
Agency code: HHS-FDA
Award floor: $0
Award ceiling: $0
Cost sharing required: No
Funding Instrument Types
- Grant
Category of Funding Activity
- Agriculture
- Consumer Protection
- Food and Nutrition
Eligible Applicants
- Others
Tools
Categories (use these for quoted searches)
- agency_code:hhs_fda
- category_of_funding_activity:agriculture
- category_of_funding_activity:consumer_protection
- category_of_funding_activity:food_and_nutrition
- cost_sharing_or_matching_requirement:false
- eligible_applicants:others
- funding_instrument_type:grant
- opportunity_category:discretionary
- status:open
Description
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.