New GDUFA Workload Formula Will Not Include Inspections Until FY 2025 Fee-Setting

 
• By Derrick Gingery

Capacity planning adjustment that will help calculate generic drug user fees will not include inspections at first to allow more time for time reporting system implementation.

workload
The new GDUFA capacity planning adjustment will include submissions, amendments, postmarket safety activities and other items. • Source: Shutterstock

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