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New Workload Categories Add To FDA Staff Needs, Help Increase User Fees

 
• By Derrick Gingery

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.

workload
Postmarketing document reviews have been added to the workload formula that helps set user fees. • Source: Shutterstock

Postmarketing work is now part of user fee calculations and could add to the US Food and Drug Administration’s staffing needs, as well as increase industry’s costs, in the coming years.

The number of annual reports, postmarketing requirements and commitment reviews, as well as active REMS document reviews are among the...

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