FDA expects to receive 51 rare pediatric disease designation requests and 20 priority review voucher requests annually. It also estimates that 3 vouchers will be redeemed and 2 will be sold per year. (See the Federal Register notice).
Since the passage of the Creating Hope Act in 2012, 19 new rare pediatric disease medicines were awarded priority review vouchers. See the full list.
The revised draft guidance incorporates public comments received on the initial draft and provides FDA’s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease.
The full draft guidance text: Rare Pediatric Disease Priority Review Vouchers — Guidance for Industry.