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FY 2003 Performance Report to Congress

Table of Contents

Executive Summary

Introduction

Overview of PDUFA

REPORT ON FY 2002 and 2003 PDUFA GOALS

Original New Product Applications

Resubmitted New Product Applications

Efficacy Supplements

Manufacturing Supplements

Resubmitted Efficacy Supplements

First Cycle Filing 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

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