Office of Orphan Products Development

Office of Orphan Products Development (OOPD) is the Office within the U.S. Food and Drug Administration whose mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

OOPD provides incentives for sponsors to develop products for rare diseases through different programs including the Orphan Drug Designation Program, the Humanitarian Use Device (HUD) Program, and the Rare Pediatric Disease Priority Review Voucher Program. OOPD also administers extramural grants programs.

Sourced From
U.S. Food and Drug Administration (FDA): Office of Orphan Products Development
U.S. Food and Drug Administration (FDA): Developing Products for Rare Diseases & Conditions
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