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Table of Contents

Introduction

Overview of Combination Products

Mandated Functions of the Office of Combination Products (OCP)

OCP Organizational Structure 

Report on FY 2005 OCP Activities and Impacts

Activities and Impacts for FY 2005

Prompt Assignment of Combination Products

Timely and Effective Premarket Review

Premarket Review

Consultative/Collaborative Review Process

Consistent and Appropriate Postmarket Regulation

Effective Resolution of Review Disputes

Additional Activities and Impacts

Report on FY 2005 OCP Requirements

Prompt Assignment of Combination Products

Timely and Effective Premarket Review

 Effective Resolution of Review Disputes

 Appendices

Appendix A:  Timely and Effective Premarket Review – Updated FY 2004 Data

Appendix B:  Glossary

Appendix C:  Summary of Footnotes

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