Our approach for the evaluation of the adjustments for changes in review activities for the PDUFA IV Workload Adjuster included the performance of the following tasks:
- Discussed with FDA the objectives of this study pertaining to the scope described above.
- Held meetings with the FDA team and center staffs to gain an understanding of the terminology and processes associated with the PDUFA IV Workload Adjuster.
- Obtained information on the methodology and calculations associated with the PDUFA IV Workload Adjuster.
- Made data requests based on currently available data.
- Used data received and knowledge gained through meetings to design alternative models and implement several data analysis techniques in an attempt to make an assessment on the adjustments for changes in review activities.
- Provided observations and suggestions to FDA based on the results of the data analysis and assessment.
- Assisted FDA with understanding our methodologies and analysis techniques and discussed potential recommendations and the viability of their implementation with currently available data.
This report documents the assessment of the adjustments for changes in review activities, as well as the potential modifications to the methodology for calculating the adjustments for changes in review activities.