US FDA Biosimilar User Fee Collections, Expenditures Hit A High Point In 2017
For the first time since the biosimilar user fee program began, FDA spent more in fees than it collected, and more than it spent in appropriated funds.
You may also be interested in...
Adello’s Filgrastim Biosimilar Faces Infringement Lawsuit And Potential Regulatory Delay
US FDA user fee date for privately held company’s 351(k) application referencing Amgen’s Neupogen may have passed without word of a regulatory action; Amgen sued Adello in March alleging infringement of 17 patents covering the innovator product.
The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees
Agency will substantially reduce amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal 2022; carryover generic drug and biosimilar fees will go toward hiring term-limited employees and building capacity, but a technical issue will keep FDA from accessing $79m in PDUFA fees.
NDA User Fees Will Climb Almost 16% On Oct. 1
US FDA completes updates for biosimilars and novel drug fee schedules as PDUFA VI is set to begin.