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The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees

Executive Summary

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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