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Generic Drug User Fee Program Sees First-Ever Fee Spending Decrease, FTE Decline

Executive Summary

Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.

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