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FDA Rare Pediatric Disease Designation

Category: Biotech Service

Exhibitor: ONLY ORPHANS COTE LLC

Booth No: L724

Characteristic

The RPDD is a status granted by the FDA to a drug or biologic product intended to treat a rare disease that primarily affects children, commonly referred to as pediatric rare diseases. The designation was established as part of the FDA Safety and Innovation Act (FDASIA) of 2012 to incentivize the development of therapies specifically targeting rare diseases in the pediatric population. The benefits include Priority Review Voucher (PRV), market exclusivity, and financial incentives.

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