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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 2006 OCP Activities and Impacts

Overview of Activities and Impacts

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 2006 OCP Requirements

Prompt Assignment of Combination Products

Timely and Effective Premarket Review

 Effective Resolution of Review Disputes

 Appendices

Appendix ATimely and Effective Premarket Review – Updated FY 2005 Data

Appendix BSummary of Footnotes

Commissioner's Report/Executive Summary

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