For Industry
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Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009 -- Final Report
March 31, 2009
Prepared by Deloitte & Touche, LLP
Contract No. GS 32F-8132H
Order No. HHSF223200830330G
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Table of Contents
Background Objectives and Scope of the Study Project Methodology Work Performed: Understanding of the FDA Methodology Evaluation And Study Assumptions Data Collection And Validation Approach And Results Observations Summary Of Assessment Appendix A: Diagram of PDUFA IV Workload Adjuster Appendix B: Supporting Information for Monte Carlo Analysis Appendix C: Documents Provided By Client Appendix D: Methodology For The Alternative Workload Adjuster With Weighted Time Reporting Glossary Glossary
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