Essentials of Healthcare Product Labeling
v
Tables
Table 3-1. Typical Functional Representation on Medical Device Labeling Teams........................... 14
Table 3-2. Package and IFU Labeling................................................................................................ 15
Table 4-1. Distinctions Between Core Labeling and Regional and Local Data Sheets..................... 20
Table 4-2. Content of the CCDS....................................................................................................... 22
Table 4-3. Sample Structure of CCDS............................................................................................... 23
Table 4-4. Sample Mechanisms to Distinguish Optional Text Within a CCDS. ..............................23
Table 4-5. Distribution Package......................................................................................................... 25
Table 4-6. Sample Justification for Discrepancy Between Local Labeling and CCDS. .....................27
Table 4-7. Elements to Be Specified in Procedures Governing the Maintenance and
Implementation of Core Labeling..................................................................................... 28
Table 4-8. Reference Product Information Used for Expedited and Periodic Safety Reporting. .......29
Table 5-1. Laws and Amendments Relating to Pharmaceutical Labeling in the US. ........................34
Table 5-2. Required Elements for Container Labels of Prescription Drugs and Biologics. ...............37
Table 5-3. Required Sections of Prescribing Information for Drugs and Biologics in the US
(PLR Format).................................................................................................................... 38
Table 5-4. Some Reasons for Labeling Revision. ...............................................................................43
Table 6-1. Action Plan Criteria for Defining Useful Information...................................................... 56
Table 6-2. Patient-Oriented Prescription Drug Labeling. .................................................................58
Table 6-3. Labeling Regulations for Nonprescription Medicines....................................................... 63
Table 7-1. SmPC Content................................................................................................................. 69
Table 7-2. Package Leaflet Content. ..................................................................................................72
Table 7-3. Linguistic Review Process (Centralized Procedure). .........................................................75
Table 8-1. Product Monograph Master Template Sections................................................................ 87
Table 9-1. CDFT Sections................................................................................................................. 95
Table 14-1. Select Resources on Pictogram Use................................................................................. 146
Table 17-1. Distinction Between Target Profiles and Target Labeling Documents........................... 184
Table 17-2. Milestones in the Evolution of Target Labeling as a Drug Development Tool............... 186
Table 17-3. FDA’s Target Product Profile – Indications and Usage Section....................................... 187
Table 17-4. Target Labeling, Sample Tabular Structure for General Use........................................... 188
Table 18-1. EU Clinical Trials Regulation Annex VI Labeling Requirements (Mandatory Items
in Shaded Boxes)............................................................................................................. 196
Table 18-2. European Free Trade Association Language Requirements for Investigational
Medicinal Products......................................................................................................... 200
Table 19-1. Important Consumer Information to Include in Cannabis Labeling.............................. 206
Table 19-2. Links to State-Specific Labeling and Packaging Regulations. ........................................207
Table 19-3. Stakeholder-Unique Recommendations for Cannabis Labeling. ....................................209
Table 19-4. National Cannabis Industry Association Recommendations for Cannabis Packaging.... 210
Table 19-5. Categories of CBD Products........................................................................................... 211
Index......................................................................................................................................................215
v
Tables
Table 3-1. Typical Functional Representation on Medical Device Labeling Teams........................... 14
Table 3-2. Package and IFU Labeling................................................................................................ 15
Table 4-1. Distinctions Between Core Labeling and Regional and Local Data Sheets..................... 20
Table 4-2. Content of the CCDS....................................................................................................... 22
Table 4-3. Sample Structure of CCDS............................................................................................... 23
Table 4-4. Sample Mechanisms to Distinguish Optional Text Within a CCDS. ..............................23
Table 4-5. Distribution Package......................................................................................................... 25
Table 4-6. Sample Justification for Discrepancy Between Local Labeling and CCDS. .....................27
Table 4-7. Elements to Be Specified in Procedures Governing the Maintenance and
Implementation of Core Labeling..................................................................................... 28
Table 4-8. Reference Product Information Used for Expedited and Periodic Safety Reporting. .......29
Table 5-1. Laws and Amendments Relating to Pharmaceutical Labeling in the US. ........................34
Table 5-2. Required Elements for Container Labels of Prescription Drugs and Biologics. ...............37
Table 5-3. Required Sections of Prescribing Information for Drugs and Biologics in the US
(PLR Format).................................................................................................................... 38
Table 5-4. Some Reasons for Labeling Revision. ...............................................................................43
Table 6-1. Action Plan Criteria for Defining Useful Information...................................................... 56
Table 6-2. Patient-Oriented Prescription Drug Labeling. .................................................................58
Table 6-3. Labeling Regulations for Nonprescription Medicines....................................................... 63
Table 7-1. SmPC Content................................................................................................................. 69
Table 7-2. Package Leaflet Content. ..................................................................................................72
Table 7-3. Linguistic Review Process (Centralized Procedure). .........................................................75
Table 8-1. Product Monograph Master Template Sections................................................................ 87
Table 9-1. CDFT Sections................................................................................................................. 95
Table 14-1. Select Resources on Pictogram Use................................................................................. 146
Table 17-1. Distinction Between Target Profiles and Target Labeling Documents........................... 184
Table 17-2. Milestones in the Evolution of Target Labeling as a Drug Development Tool............... 186
Table 17-3. FDA’s Target Product Profile – Indications and Usage Section....................................... 187
Table 17-4. Target Labeling, Sample Tabular Structure for General Use........................................... 188
Table 18-1. EU Clinical Trials Regulation Annex VI Labeling Requirements (Mandatory Items
in Shaded Boxes)............................................................................................................. 196
Table 18-2. European Free Trade Association Language Requirements for Investigational
Medicinal Products......................................................................................................... 200
Table 19-1. Important Consumer Information to Include in Cannabis Labeling.............................. 206
Table 19-2. Links to State-Specific Labeling and Packaging Regulations. ........................................207
Table 19-3. Stakeholder-Unique Recommendations for Cannabis Labeling. ....................................209
Table 19-4. National Cannabis Industry Association Recommendations for Cannabis Packaging.... 210
Table 19-5. Categories of CBD Products........................................................................................... 211
Index......................................................................................................................................................215