FDA Sets $2.73M as FY 2016 User Fee for Pediatric Vouchers

The FDA announced that the fee for using a rare pediatric disease priority review voucher for fiscal year 2016 is $2.73 million, according to a notice to be published Sept. 28 in the Federal Register.

The fee for applications submitted with a priority review voucher is in addition to the normal Prescription Drug User Fee Act (PDUFA) fee, the Food and Drug Administration said. This rate is effective Oct. 1 through Sept. 30, 2016.

Priority review vouchers are issued to sponsors of rare pediatric disease product applications and entitle the holder to priority review of a single new drug application ...