Regulatory Affairs Professionals Society ix
Section VI: Postmarketing Authorization
Chapter 29: Postauthorization Commitments .............................................................................................................................................467
Karin McIntosh, MPharm, RAC-Drugs
Chapter 30: Transfers and Renewals ............................................................................................................................................................477
Pallavi Trivedi, MPH Rudradutt Singh Vaghela, PhD, RAC-Drugs
Chapter 31: Product Extensions, Variations, and Supplements ...................................................................................................................495
Karin McIntosh, MPharm, RAC-Drugs
Chapter 32: Compliance............................................................................................................................................................................... 517
Siegfried Schmitt, PhD Barbara A. Rusin, MS
Chapter 33: Recalls .......................................................................................................................................................................................531
Siegfried Schmitt, PhD
Chapter 34: Postmarket Surveillance ............................................................................................................................................................535
Pallavi Trivedi, MPH Siegfried Schmitt, PhD Cansın Gevrek, BS
Chapter 35: Advertising and Promotion ......................................................................................................................................................551
Timothy A. Candy, PharmD, MS, BCPS Sue Duvall, MPA, RN, BS Kathleen Grim, MS Rebecca Lalani, PharmD
Chapter 36: Market Access: Reimbursement and Pricing ............................................................................................................................567
Pallavi Trivedi, MPH Rudradutt Singh Vaghela, PhD, RAC-Drugs
Glossary, Abbreviations, and Acronyms ........................................................................................................603
Index ............................................................................................................................................................637
Case Studies
Case Study 4-1 ...............................................................................................................................................................................................46
Case Study 4-2 ...............................................................................................................................................................................................47
Case Study 5-1 ...............................................................................................................................................................................................61
Case Study 10-1 ...........................................................................................................................................................................................117
Case Study 11-1 ...........................................................................................................................................................................................130
Case Study 19-1 ...........................................................................................................................................................................................269
Case Study 19-2 ...........................................................................................................................................................................................271
Case Study 19-3 ...........................................................................................................................................................................................272
Case Study 22-1 ...........................................................................................................................................................................................314
Case Study 22-2 ...........................................................................................................................................................................................314
Case Study 22-3 ...........................................................................................................................................................................................317
Case Study 22-4 ...........................................................................................................................................................................................318
Case Study 22-5 ...........................................................................................................................................................................................319
Case Study 22-6 ...........................................................................................................................................................................................320
Case Study 26-1 ...........................................................................................................................................................................................394
Case Study 35-1 ...........................................................................................................................................................................................562
Section VI: Postmarketing Authorization
Chapter 29: Postauthorization Commitments .............................................................................................................................................467
Karin McIntosh, MPharm, RAC-Drugs
Chapter 30: Transfers and Renewals ............................................................................................................................................................477
Pallavi Trivedi, MPH Rudradutt Singh Vaghela, PhD, RAC-Drugs
Chapter 31: Product Extensions, Variations, and Supplements ...................................................................................................................495
Karin McIntosh, MPharm, RAC-Drugs
Chapter 32: Compliance............................................................................................................................................................................... 517
Siegfried Schmitt, PhD Barbara A. Rusin, MS
Chapter 33: Recalls .......................................................................................................................................................................................531
Siegfried Schmitt, PhD
Chapter 34: Postmarket Surveillance ............................................................................................................................................................535
Pallavi Trivedi, MPH Siegfried Schmitt, PhD Cansın Gevrek, BS
Chapter 35: Advertising and Promotion ......................................................................................................................................................551
Timothy A. Candy, PharmD, MS, BCPS Sue Duvall, MPA, RN, BS Kathleen Grim, MS Rebecca Lalani, PharmD
Chapter 36: Market Access: Reimbursement and Pricing ............................................................................................................................567
Pallavi Trivedi, MPH Rudradutt Singh Vaghela, PhD, RAC-Drugs
Glossary, Abbreviations, and Acronyms ........................................................................................................603
Index ............................................................................................................................................................637
Case Studies
Case Study 4-1 ...............................................................................................................................................................................................46
Case Study 4-2 ...............................................................................................................................................................................................47
Case Study 5-1 ...............................................................................................................................................................................................61
Case Study 10-1 ...........................................................................................................................................................................................117
Case Study 11-1 ...........................................................................................................................................................................................130
Case Study 19-1 ...........................................................................................................................................................................................269
Case Study 19-2 ...........................................................................................................................................................................................271
Case Study 19-3 ...........................................................................................................................................................................................272
Case Study 22-1 ...........................................................................................................................................................................................314
Case Study 22-2 ...........................................................................................................................................................................................314
Case Study 22-3 ...........................................................................................................................................................................................317
Case Study 22-4 ...........................................................................................................................................................................................318
Case Study 22-5 ...........................................................................................................................................................................................319
Case Study 22-6 ...........................................................................................................................................................................................320
Case Study 26-1 ...........................................................................................................................................................................................394
Case Study 35-1 ...........................................................................................................................................................................................562