1. Pink Sheet

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

Fiscal year 2024 generic drug user fee calculations will incorporate a new workload-based model, but not account for all of the categories initially expected.

The US Food and Drug Administration committed to incorporating a capacity planning adjustment into GDUFA III fee calculations as part of the 2022 program reauthorization. Inspections are supposed to be...

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