Supports clinical trial grants for orphan products including drugs, biologics, medical devices, and foods for medical purposes targeting rare diseases affecting fewer than 200,000 people in the U.S. Trials must evaluate efficacy and/or safety to support new indications or labeling changes addressing unmet needs in rare diseases or conditions.
Eligible applicants include foreign or domestic, public or private, for-profit or nonprofit entities, including state and local governments. Federal agencies are not eligible to apply.
