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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:

2013 and 2014 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)


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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