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Information on the OOPD Grant Program

The goal of the Office of Orphan Products Development Grant Program is to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting fewer than 200,000 people in the United States. The products studied can be drugs, biologics, medical devices, or medical foods. Grant applications are solicited through a Request for Applications (RFA) published in the Federal Register, and available on this website.

What studies qualify?

At this time, only clinical studies qualify for consideration. Each application should propose one discrete clinical study to facilitate FDA approval of the product for a rare disease or condition. The study may address an unapproved new product or an unapproved new use for a product already on the market. All studies must be conducted under an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). Medical foods are the only exception to this requirement.

• Click here for a list of products that have been approved as a result of OOPD funded grants.

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FDA Office of Orphan Products Development