What studies qualify for orphan product grants?
Only clinical studies qualify for consideration. Each application should propose one discrete clinical study designed to facilitate FDA approval of the product for use in 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. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.
Related Questions
- I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
- What if I am interested in providing a product or service, but do not qualify as a US–based diverse enterprise within the Limited Brands Supplier Diversity initiative?
- How much money is available for orphan product grants?
