User fees increase
Executive Summary
User fees for fiscal 2003 increase 70% over prior year, according to rates announced in the Federal Register Aug. 2. Prescription Drug User Fee Act fees will be $533,400 for an application requiring clinical data; $266,700 for an application not requiring clinical data or a supplement requiring clinical data; $209,900 for establishment fees; and $32,400 for product fees. FY 2002 adjusted fees were $313,320 for applications requiring clinical data and $156,660 for applications not requiring clinical data or supplements requiring clinical data....