For Industry

Orphan Products Clinical Trials Grants Program

The goal of the Orphan Products Clinical Trials Grants Program (formerly known as Orphan Products Grants) 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

ClinicalTrials.Gov

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

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

For Orphan Grants, and Natural History Grants Programs: Mary.Limon

For Pediatric Device Consortia Grants: Eric.Chen

Page Last Updated: 10/17/2016
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