xi
Figure 4-3. EU Legal Instruments. .................................................................................................................................................67
Figure 4-4. Inspections as Part of the Drug Approval Process. .......................................................................................................68
Figure 6-1. Failure Mode and Effect Analysis Cycle....................................................................................................................... 96
Figure 6-2. Three-step RPN-based Risk Evaluation. ......................................................................................................................99
Figure 6-3. Example of QRM in Action....................................................................................................................................... 100
Figure 9-1. Strategy for Performing Animal Studies..................................................................................................................... 128
Figure 16-1. NDC Number Example. ..........................................................................................................................................218
Figure 16-2. Trade Bottle Label. ...................................................................................................................................................225
Figure 16-3. Small Container Label (Small Label Exemption Rule)............................................................................................ 225
Figure 16-4. Folding Carton for Pharmaceutical Drug Product. ..................................................................................................228
Figure 16-5. Biologic Label........................................................................................................................................................... 231
Figure 16-6. Biologic Carton Label.............................................................................................................................................. 231
Figure 19-1. Acceptance of Foreign Clinical Data. .......................................................................................................................301
Figure 19-2. Quality Management System. ..................................................................................................................................306
Figure 22-1. Types of Pharmaceutical and Biologic Clinical Trials and Typical Pathway. ............................................................342
Figure 22-2. Types of Medical Device Clinical Trials and Typical Pathway.................................................................................. 361
Figure 23-1. TPLC Cycle for Devices.......................................................................................................................................... 379
Figure 23-2. Medical Device Design Control and Review Process............................................................................................... 380
Figure 28-1. The Risk Management Process. ................................................................................................................................425
Figure 28-2. Principal Activities for Risk Management................................................................................................................ 427
Figure 28-3. The Risk Management Process. ................................................................................................................................430
Sidebars
Sidebar 18-1. Enforcement Example Mirapex 9/2008.................................................................................................................. 251
Sidebar 18-2. Enforcement Example Focalin XR 5/2011. ............................................................................................................265
Sidebar 18-3. Enforcement Example Idelvion, 2/2018................................................................................................................. 269
Sidebar 18-4. Enforcement Example Estring 6/2018. ..................................................................................................................270
Sidebar 18-5. Enforcement Example Vantas 9/2012..................................................................................................................... 273
Sidebar 18-6. Enforcement Example Contrave 5/2017................................................................................................................. 276
Sidebar 18-7. Enforcement Example Muse 5/2004 and 4/1998. ..................................................................................................277
Sidebar 18-8. Enforcement Examples MiraLax 3/2001 and Patanol 3/2001................................................................................ 279
Sidebar 18-9. Enforcement Example Tasigna 7/2010. ..................................................................................................................284
Sidebar 18-10. Enforcement Example NCS Pearson 8/2015........................................................................................................ 289
Figure 4-3. EU Legal Instruments. .................................................................................................................................................67
Figure 4-4. Inspections as Part of the Drug Approval Process. .......................................................................................................68
Figure 6-1. Failure Mode and Effect Analysis Cycle....................................................................................................................... 96
Figure 6-2. Three-step RPN-based Risk Evaluation. ......................................................................................................................99
Figure 6-3. Example of QRM in Action....................................................................................................................................... 100
Figure 9-1. Strategy for Performing Animal Studies..................................................................................................................... 128
Figure 16-1. NDC Number Example. ..........................................................................................................................................218
Figure 16-2. Trade Bottle Label. ...................................................................................................................................................225
Figure 16-3. Small Container Label (Small Label Exemption Rule)............................................................................................ 225
Figure 16-4. Folding Carton for Pharmaceutical Drug Product. ..................................................................................................228
Figure 16-5. Biologic Label........................................................................................................................................................... 231
Figure 16-6. Biologic Carton Label.............................................................................................................................................. 231
Figure 19-1. Acceptance of Foreign Clinical Data. .......................................................................................................................301
Figure 19-2. Quality Management System. ..................................................................................................................................306
Figure 22-1. Types of Pharmaceutical and Biologic Clinical Trials and Typical Pathway. ............................................................342
Figure 22-2. Types of Medical Device Clinical Trials and Typical Pathway.................................................................................. 361
Figure 23-1. TPLC Cycle for Devices.......................................................................................................................................... 379
Figure 23-2. Medical Device Design Control and Review Process............................................................................................... 380
Figure 28-1. The Risk Management Process. ................................................................................................................................425
Figure 28-2. Principal Activities for Risk Management................................................................................................................ 427
Figure 28-3. The Risk Management Process. ................................................................................................................................430
Sidebars
Sidebar 18-1. Enforcement Example Mirapex 9/2008.................................................................................................................. 251
Sidebar 18-2. Enforcement Example Focalin XR 5/2011. ............................................................................................................265
Sidebar 18-3. Enforcement Example Idelvion, 2/2018................................................................................................................. 269
Sidebar 18-4. Enforcement Example Estring 6/2018. ..................................................................................................................270
Sidebar 18-5. Enforcement Example Vantas 9/2012..................................................................................................................... 273
Sidebar 18-6. Enforcement Example Contrave 5/2017................................................................................................................. 276
Sidebar 18-7. Enforcement Example Muse 5/2004 and 4/1998. ..................................................................................................277
Sidebar 18-8. Enforcement Examples MiraLax 3/2001 and Patanol 3/2001................................................................................ 279
Sidebar 18-9. Enforcement Example Tasigna 7/2010. ..................................................................................................................284
Sidebar 18-10. Enforcement Example NCS Pearson 8/2015........................................................................................................ 289