1. Pink Sheet

US FDA Reports Millions In Unpaid GDUFA Program Fees

 
• By Derrick Gingery

The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.

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The GDUFA carryover balance still increased in FY 2018 because collections again outpaced obligations. • Source: Shutterstock

Generic drug application holders shorted the US Food and Drug Administration a substantial amount of user fees in calendar year 2018.

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