International Combination Products
iii
Table of Contents
Section I: General Information
Chapter 1 What are Combination Products?.........................................................................................1
Chapter 2 Regulatory Strategy...............................................................................................................9
Section II: North America: US and Canada
Chapter 3 US FDA Structure, Office of Combination Products, and Combination Products
Policy Council.....................................................................................................................17
Chapter 4 Jurisdiction and Regulatory Pathway. .................................................................................31
Chapter 5 Combination Product Development and Meetings. ...........................................................43
Chapter 6 Investigational Use and Human Factors. ............................................................................55
Chapter 7 Current Good Manufacturing Practice (CGMP). ..............................................................67
Chapter 8 Marketing Applications, Premarket Review Pathways, and User Fees................................77
Chapter 9 Combination Product Review Process and Labeling. .........................................................93
Chapter 10 Postapproval Modifications...............................................................................................105
Chapter 11 Postmarket Safety Reporting. ...........................................................................................115
Chapter 12 Canadian Combination Products......................................................................................127
Section III: Europe
Chapter 13 European Union Combination Products...........................................................................143
Acronyms. ..............................................................................................................................................157
Glossary..................................................................................................................................................159
Index......................................................................................................................................................171
Figures
Figure 2-1. Example Regulatory Strategy Document Template............................................................14
Figure 3-1. FDA Organization Leadership Chart.................................................................................19
Figure 3-2. CBER Leadership Chart. ...................................................................................................21
iii
Table of Contents
Section I: General Information
Chapter 1 What are Combination Products?.........................................................................................1
Chapter 2 Regulatory Strategy...............................................................................................................9
Section II: North America: US and Canada
Chapter 3 US FDA Structure, Office of Combination Products, and Combination Products
Policy Council.....................................................................................................................17
Chapter 4 Jurisdiction and Regulatory Pathway. .................................................................................31
Chapter 5 Combination Product Development and Meetings. ...........................................................43
Chapter 6 Investigational Use and Human Factors. ............................................................................55
Chapter 7 Current Good Manufacturing Practice (CGMP). ..............................................................67
Chapter 8 Marketing Applications, Premarket Review Pathways, and User Fees................................77
Chapter 9 Combination Product Review Process and Labeling. .........................................................93
Chapter 10 Postapproval Modifications...............................................................................................105
Chapter 11 Postmarket Safety Reporting. ...........................................................................................115
Chapter 12 Canadian Combination Products......................................................................................127
Section III: Europe
Chapter 13 European Union Combination Products...........................................................................143
Acronyms. ..............................................................................................................................................157
Glossary..................................................................................................................................................159
Index......................................................................................................................................................171
Figures
Figure 2-1. Example Regulatory Strategy Document Template............................................................14
Figure 3-1. FDA Organization Leadership Chart.................................................................................19
Figure 3-2. CBER Leadership Chart. ...................................................................................................21