Everything Old is New Again: FDA Revises its 2014 Rare Pediatric Disease Priority Review Voucher Guidance for Industry

Offering priority review vouchers to sponsors that develop new drugs for children with rare diseases is an important incentive program that has wide support.  This week, FDA published a revised draft guidance of the original November 2014 draft guidance titled, “Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry” (hereinafter “revised guidance”).