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

 
• By Sue Sutter and Derrick Gingery

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.

Woman counting dollars at table

In a move that should please industry, the US FDA intends to substantially reduce the amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal year 2022.

However, FDA's targeted reduction of $159.2m in carryover balances over the next five years could leave the agency with less...

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