New Workload Categories Add To FDA Staff Needs, Help Increase User Fees
Postmarketing activities, such as REMS document and annual report reviews, are now part of the formula used to account for workload changes in user fee calculations, which likely helped push fees higher in fiscal year 2024.
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Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.
ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program.
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.