Objectives and Scope of the Study
FDA engaged Deloitte to conduct an evaluation of the adjustment for changes in review activities applied to the PDUFA IV Workload Adjuster for setting PDUFA user fees for FY 2009, and to make appropriate recommendations for change, if warranted. After considering potential recommendations from the study, FDA may change the workload adjustment methodology for setting fees for FY 2010 through FY 2012.
The objectives of this study are to:
- Assess the validity of the adjustments for changes in review activities within the PDUFA IV Workload Adjuster that are applied in setting fees for FY 2009.
- Make recommendations, if warranted, for future changes to the methodology for calculating the adjustments for changes in review activities, using existing or currently available data collected by FDA.
The scope of this study includes an assessment of the adjustments for future changes in review activities in the PDUFA IV Workload Adjuster. Validation of FDA’s standard cost model and review of the design and operation of time reporting systems are beyond the scope of this study.