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FY 2004 PDUFA FINANCIAL REPORT

required by the

Prescription Drug User Fee Act of 1992

as amended by the

Food and Drug Administration
Modernization Act of 1997

and by the

Prescription Drug User Fee Amendments of 2002

Food and Drug Administration
Department of Health and Human Services

March 2005

This Report is available in printer-friendly PDF format (102 KB)

Table of Contents

Letter to Congress

Executive Summary

The Report

Background

Meeting the Legal Conditions for User Fees in FY 2004

User Fee Revenues

Obligation of User Fee Revenues

Carryover Balances

Total Costs of the Process for the Review of Human Drug Applications

Management Challenges for FY 2005

Appendices

Appendix A: Conditions for Assessment and Use of Fees

Appendix B: Exemptions and Waivers

Appendix C: Allowable and Excluded Costs for the Process for the Review of Human Drug Applications

Appendix D: Development of Costs for the Process for the Review of Human Drug Applications

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