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

 
• By Derrick Gingery

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.

A toy train pulling a cargo of money This picture could be a reference to 'money delivery', gravy train, cargo, freight. Also, money supply and transferring money or wiring money.
Overall GDUFA spending increased in FY 2019, but user fee revenue spending did not. • Source: Shutterstock

Add financial and personnel firsts to the record-breaking fiscal year 2019 performance of the US Food and Drug Administration’s generic drug user fee program.

FDA officials touted the new all-time high ANDA approval and tentative approval total set that year in the opening of its FY 2019 financial report. But the report also...

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