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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:

 

 Application Process:

 

Other Useful Links:

Information for Sponsor-Investigators submitting Investigational New Drug applications (INDs) or Investigational Device Exemptions (IDEs)
 
Guidance:

 

 

Contact FDA

(301) 796-8660
Office of Orphan Product Development

For Designations, contact: Jeff.Fritsch

For Grants, contact: Mary.Limon

For Devices, contact: James.Bona

For Pediatric Device Consortia, contact: Linda.Ulrich

For Questions Email: orphan@fda.hhs.gov

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