FDA Sets Updated Priority Review Voucher Fee Levels
The FDA has posted its fees for priority review vouchers for fiscal 2018.
Applications submitted with rare pediatric disease priority review vouchers, in addition to normal PDUFA fees, will cost $2,830,579 in fiscal 2018. The same will apply to applications submitted with a tropical disease priority review voucher.
For the new fee levels, the FDA must adjust the incremental cost from fiscal 2016 by the average amount costs rose in the three years before the current fiscal year, according to the agency.