Rare Pediatric Disease Designation and Priority Review Voucher Programs to Sunset in Sept 2024
The rare pediatric disease Priority Review Vouchers (PRV) program, which aims to incentivize drug development for rare pediatric diseases will be sunsetting after September 30th, 2024. Under this voucher program, a sponsor who obtains approval for a drug or biological product targeting a rare pediatric disease may be eligible for a voucher that grants priority review for a different product. The sponsor can also transfer or sell the voucher to another sponsor. The FDA grants these PRVs to sponsors of approved products that meet specific criteria for rare pediatric diseases. Before submitting a marketing application for their drug, sponsors intending to request a rare pediatric disease PRV can apply for a rare pediatric disease designation.
Rare Pediatric Disease Designation and Priority Review Voucher Programs to Sunset in Sept 2024