1. Pink Sheet

FDA May Not Implement User Fee Workload Adjuster In PDUFA VI

 
• By Derrick Gingery

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.

A report commissioned by the US FDA lays out the tasks required to create the necessary infrastructure and produce new algorithms. The goal is a formula that would allow...

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