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U.S. Department of Health and Human Services

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:


 2015 through 2018 Submission Dates:


Other Useful Links:

Sponsor Investigator Roles and Responsibilities in Clinical Investigations 


Choose one the following Center links for information for Sponsor-Investigators submitting Investigational New Drug applications (INDs) or Investigational Device Exemptions (IDEs)






Contact FDA

(301) 796-8660

For Orphan Drug Designations: Jeff.Fritsch (non-oncology)

For Orphan Drug Designations(oncology), Devices, and Rare Pediatric Disease Designations: James.Bona

For Orphan Grants: Mary.Limon

For Pediatric Device Consortia Grants: Linda.Ulrich