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FY 2004 PERFORMANCE REPORT TO THE PRESIDENT AND THE CONGRESS
for the
Prescription Drug User Fee Act of 1992
As reauthorized and amended by the
Food and Drug Administration Modernization Act of 1997
And the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Food and Drug Administration
Department of Health and Human Services

TABLE OF CONTENTS

Commissioner's Report

Executive Summary

Introduction

Overview of PDUFA

Report on FY 2003 and 2004 PDUFA Goals

• Original Applications
• Resubmitted Applications
• Efficacy Supplements
• Resubmitted Efficacy Supplements
• Manufacturing Supplements
• First Cycle Filing Review Notification
• Reviewable Unit Letter Notification
• Procedural and Processing Goals

PDUFA III Management Initiatives

Electronic Applications and Submissions

Appendices

• Appendix A:   PDUFA Performance Goals, FY 2002 - FY 2007
• Appendix B:   List of Approved Applications

Print version of this report [PDF, 1.1 MB]

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FY 2004 PDUFA Performance Report | Commissioner's Report

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