2026
An estimated 0 designations were granted, and 0 priority review vouchers were awarded.
0 vouchers were sold for a total of $0 million.
Planting the seeds of rare disease research
The FDA's Rare Pediatric Disease Designation Priority Review Voucher Program has planted the seeds for 76 new rare disease treatments, 60 of them the first approved therapy for their condition. The program lapsed at the end of 2024. Congress renewed it in February 2026 through the Mikaela Naylon Give Kids a Chance Act, and 2026 is its most fruitful year yet, with 13 vouchers awarded.