FDA May Not Implement User Fee Workload Adjuster In PDUFA VI

Three-to-five year timeline needed to develop algorithms does not engender confidence that new version of formula, which historically pushed user fee rates higher, will be ready before PDUFA VII begins.

Close up of blackboard for coaching tactics and strategies

A new resource capacity adjustment method that could significantly impact the user fees paid by sponsors may not arrive before the end of PDUFA VI.

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Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

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