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.
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User fees for NDAs including OTC switches were set to increase nearly 11% from FY2021 but could have gone even higher; a new notice will be issued but timing is unclear.
User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.
The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.