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  3. Medical products for rare diseases and conditions
  4. Grant Programs to Support Development of Medical Products for Rare Diseases
  5. Funding Opportunities for Rare Disease Research
  1. Grant Programs to Support Development of Medical Products for Rare Diseases

Funding Opportunities for Rare Disease Research

FDA Office of Orphan Products Development (OOPD) rare disease research grants

Clinical Trials 

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)
Apply Here

Receipt Dates: October 22, 2024 (for new applications and resubmissions)
Resubmissions only 
Due Date: June 3, 2025 (for resubmissions only)
FOA Number: RFA-FD-23-001
Users can also subscribe for automatic notifications on grants.gov.

Funding Opportunity Purpose:
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. 

Learn more about this program: Clinical Trials Grants Program.

Also see instructions and helpful hints (PDF) for applying for clinical trial grants and FAQs.

Natural History Studies

Please check back for future opportunities. For reference, the most recent funding opportunity announcement is from FY 2024. 

Learn more about this program: Natural History Studies Grant Program. 

Rare Neurodegenerative Disease Grants Program Opportunities

Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
Apply Here

Receipt Dates: October 22, 2024 and October 21, 2025
FOA Number: RFA-FD-25-001
Users can also subscribe for automatic notifications on grants.gov.
 
Funding Opportunity Purpose:
The purpose of this funding opportunity announcement (FOA) 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 neurodegenerative diseases for children and adults. Through the support of collaborative, efficient and innovative clinical trials, FDA hopes to exert a broad and positive impact by increasing the number of approved medical products for rare neurodegenerative diseases. 

See instructions and helpful hints (PDF) for applying for rare neurodegenerative disease grants. 

Learn more about this program: Rare Neurodegenerative Disease Grants Program. 

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