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Comments Sought on PDUFA Workload Adjuster

05/07/2013

Federal Register Notice: FDA is seeking public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent consulting firm. This assessment was conducted to fulfill FDA performance commitments made as part of the fifth authorization of PDUFA in section XV, “Improving FDA Performance Management,” subsection B. It is the first of two assessments during PDUFA V to evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity in the human drug review program and to present options to discontinue, retain or modify any elements of the adjustment. Comments should be submitted by 6/5. To view this notice, click here.

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