Essentials of Healthcare Product Labeling
iv Regulatory Affairs Professionals Society (RAPS)
Chapter 13 Canadian Labeling for Medical Devices and In Vitro Diagnostic Devices..................... 125
Shirley Furesz, PhD, RAC-CAN
Chapter 14 Operational Considerations............................................................................................. 139
Debra Goetchius
Chapter 15 US Submissions and Launch Activities........................................................................... 161
Julie Willmes, Prashanthi Suganthan, and Luke Catanzaro
Chapter 16 EU Submissions and Launch Activities. .........................................................................175
Rosy Henschel Undari
Chapter 17 Target Product Profiles and Target Labeling................................................................... 183
Cathleen O’Connell, PhD, MS, RPh, Christine Holzmueller, and Joy Frestedt, PhD,
RAC-US, FRAPS
Chapter 18 Investigational Drug Labeling......................................................................................... 193
Karen Long, MSc, RAC-US, RAC-EU, RAC-CAN, RAC-Global
Chapter 19 Labeling and Packaging of Cannabis Products. ..............................................................203
Nadja Torres, MD, MPH, MS
Figures
Figure 2-1. Vioxx. ................................................................................................................................10
Figure 4-1. Development of CCDS and Local Labeling Documents ................................................26
Figure 5-1. Prescription Drug Labeling Sections 8.1–8.3 (Use in Specific Populations) ....................41
Figure 6-1. Patient Medication Information Example......................................................................... 61
Figure 6-2. Drug Facts Label............................................................................................................... 63
Figure 11-1. Regulation 888.3040. ......................................................................................................110
Figure 14-1. NDC Number Example.................................................................................................. 142
Figure 14-2. Trade Bottle Label........................................................................................................... 149
Figure 14-3. Small Container Label (Small Label Exemption Rule).................................................. 150
Figure 14-4. Folding Carton for Pharmaceutical Drug Product.......................................................... 152
Figure 14-5. Biologic Label. ................................................................................................................155
Figure 14-6. Biologic Carton Label..................................................................................................... 156
Figure 15-1. Information Included in the SPL.................................................................................... 165
Figure 15-2. Labeling Operations Activities in the Submission Process (black boxes). .......................168
Figure 15-3. Submission Types and Implementation Timing for Postmarketing Labeling Changes.... 169
Figure 15-4. NDA/ANDA and BLA Annual Report Submission Timing......................................... 171
Figure 15-5. Labeling Summary Sections in NDA and BLA Annual Reports. ..................................171
Figure 16-1. Product Information Elements Included in Module 1 of the Common Technical
Document (Administrative Information and Prescribing Information) in the EU. ........176
Figure 16-2. Timeline for New Applications and Extensions (Pre-Opinion) –
Mock-Up Review Points................................................................................................. 179
iv Regulatory Affairs Professionals Society (RAPS)
Chapter 13 Canadian Labeling for Medical Devices and In Vitro Diagnostic Devices..................... 125
Shirley Furesz, PhD, RAC-CAN
Chapter 14 Operational Considerations............................................................................................. 139
Debra Goetchius
Chapter 15 US Submissions and Launch Activities........................................................................... 161
Julie Willmes, Prashanthi Suganthan, and Luke Catanzaro
Chapter 16 EU Submissions and Launch Activities. .........................................................................175
Rosy Henschel Undari
Chapter 17 Target Product Profiles and Target Labeling................................................................... 183
Cathleen O’Connell, PhD, MS, RPh, Christine Holzmueller, and Joy Frestedt, PhD,
RAC-US, FRAPS
Chapter 18 Investigational Drug Labeling......................................................................................... 193
Karen Long, MSc, RAC-US, RAC-EU, RAC-CAN, RAC-Global
Chapter 19 Labeling and Packaging of Cannabis Products. ..............................................................203
Nadja Torres, MD, MPH, MS
Figures
Figure 2-1. Vioxx. ................................................................................................................................10
Figure 4-1. Development of CCDS and Local Labeling Documents ................................................26
Figure 5-1. Prescription Drug Labeling Sections 8.1–8.3 (Use in Specific Populations) ....................41
Figure 6-1. Patient Medication Information Example......................................................................... 61
Figure 6-2. Drug Facts Label............................................................................................................... 63
Figure 11-1. Regulation 888.3040. ......................................................................................................110
Figure 14-1. NDC Number Example.................................................................................................. 142
Figure 14-2. Trade Bottle Label........................................................................................................... 149
Figure 14-3. Small Container Label (Small Label Exemption Rule).................................................. 150
Figure 14-4. Folding Carton for Pharmaceutical Drug Product.......................................................... 152
Figure 14-5. Biologic Label. ................................................................................................................155
Figure 14-6. Biologic Carton Label..................................................................................................... 156
Figure 15-1. Information Included in the SPL.................................................................................... 165
Figure 15-2. Labeling Operations Activities in the Submission Process (black boxes). .......................168
Figure 15-3. Submission Types and Implementation Timing for Postmarketing Labeling Changes.... 169
Figure 15-4. NDA/ANDA and BLA Annual Report Submission Timing......................................... 171
Figure 15-5. Labeling Summary Sections in NDA and BLA Annual Reports. ..................................171
Figure 16-1. Product Information Elements Included in Module 1 of the Common Technical
Document (Administrative Information and Prescribing Information) in the EU. ........176
Figure 16-2. Timeline for New Applications and Extensions (Pre-Opinion) –
Mock-Up Review Points................................................................................................. 179