Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases
Funds clinical research for rare disease products by supporting trial design and study execution.
The FDA Office of Orphan Products Development (OOPD) Clinical Trials Grants Program, established under the Orphan Drug Act of 1983, funds clinical trials of drugs, biologics, medical devices, and foods for medical purposes indicated for rare diseases or conditions affecting fewer than 200,000 people in the United States. Diagnostics and vaccines qualify only if the U.S. population to whom they wil…
Clinical trials evaluating safety or efficacy of drugs, biologics, medical devices, or foods for medical purposes intended for rare diseases or conditions affecting fewer than 200,000 people in the United States.
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