For Industry
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Orphan Products Grants Program
The goal of the Orphan Products Grants Program is to encourage clinical development of products for use in rare diseases or conditions. The products studied can be drugs, biologics, medical devices, or medical foods. For more detailed information on the OOPD Grant Program, please review the following:
General Information:
- Information on the Orphan Products Grants Program
- Searchable Database of Orphan Product Funded Grants
- Frequently Asked Questions (FAQ)
Application Process:
October 15, 2012 Resubmission:
- Request for Applications (RFA) for Orphan Grants (Abbreviated RFA)
- NIH Guide (RFA-FD-11-001 (Detailed RFA)
- Instructions and Helpful Hints
**NEW** 2013 and 2014 Submission Dates:
- Request for Applications (RFA) for Orphan Grants: For Receipt Dates 2013 and 2014 (Abbreviated RFA)
- NIH Guide for Receipt Dates 2013 and 2014 (RFA-FD-13-001) (Detailed RFA)
- Instructions and Helpful Hints for Receipt Dates 2013 and 2014
Other Useful Links:
Information for Sponsor-Investigators submitting Investigational New Drug applications (INDs) or Investigational Device Exemptions (IDEs)
Guidance:
Contact FDA
(301) 796-8660
For Drug Designations: Jeff.Fritsch (non-oncology)
For Drug Designations: James Bona (oncology)
For Orphan Grants: Mary.Limon
For Devices: James.Bona
For Pediatric Device Consortia Grants: Linda.Ulrich
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