FDA Announces FY 2014 User Fee Rate For Tropical Disease Priority Review Vouchers

The Food and Drug Administration is announcing the fee rate for using a tropical disease priority review voucher for fiscal year 2014, according to a notice published Sept. 5 in the Federal Register (78 Fed. Reg. 54656).

The fee rate for applications submitted with a priority review voucher is $2.32 million. This is in addition to the normal Prescription Drug User Fee Act (PDUFA) fee, FDA said. This rate is effective Oct. 1 and will remain in effect through Sept. 30, 2014.

FDA collects priority review user fees for certain applications for the approval of drug or biological products when ...