FDA Increases PDUFA Program Fee For Fiscal 2021, Cites COVID Workload

FDA announced Wednesday (July 29) that it will decrease application costs for its prescription drug user fee program in fiscal 2021, but it will increase overall program fees by about $11,000 over fiscal 2020 levels, for a total of about $336,000. The agency also is increasing medical device user fees across the board in fiscal 2021. FDA, in a Federal Register notice announcing the Prescription Drug User Fee Amendment fees for fiscal 2021, says it believes it will need...