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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 A: Timely and Effective Premarket Review – Updated FY 2005 Data
Appendix B: Summary of Footnotes