Essentials of Healthcare Product Labeling
iii
Table of Contents
Chapter 1 Introduction to Healthcare Product Labeling. ....................................................................1
Cathleen O’Connell, PhD, MS, RPh
Chapter 2 Content Development ........................................................................................................5
Cathleen O’Connell, PhD, MS, RPh
Chapter 3 Content Development – Special Considerations for Medical Devices .............................13
Eleonora Chakraborty, RAC-US, RAC-EU
Chapter 4 Core Labeling.................................................................................................................... 19
Cathleen O’Connell, PhD, MS, RPh, Ameesha Batheja, PhD, and Stephanie Turri, MS
Chapter 5 Pharmaceutical Labeling in the US................................................................................... 33
Cathleen O’Connell, PhD, MS, RPh, Susan Merchant, Zahra Martinez, PharmD, RPh,
and Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
Chapter 6 Patient Labeling in the US................................................................................................ 55
Cathleen O’Connell, PhD, MS, RPh, Christine Holzmueller, and Hoi Lam Chan, MPH,
BPharm (Hons)
Chapter 7 EU Product Information................................................................................................... 67
Nicole Beard, PhD, MSc
Chapter 8 Labeling of Human Drugs in Canada............................................................................... 79
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 9 Labeling of Nonprescription Human Drugs in Canada.................................................... 91
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 10 Plain Language Labeling................................................................................................. 101
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 11 Medical Device Labeling in the US. ...............................................................................107
Rita P. Francis, PhD, MS, MBA
Chapter 12 EU Labeling for Medical Devices and In Vitro Diagnostic Medical Devices................ 117
Nicole Beard, PhD, MSc
iii
Table of Contents
Chapter 1 Introduction to Healthcare Product Labeling. ....................................................................1
Cathleen O’Connell, PhD, MS, RPh
Chapter 2 Content Development ........................................................................................................5
Cathleen O’Connell, PhD, MS, RPh
Chapter 3 Content Development – Special Considerations for Medical Devices .............................13
Eleonora Chakraborty, RAC-US, RAC-EU
Chapter 4 Core Labeling.................................................................................................................... 19
Cathleen O’Connell, PhD, MS, RPh, Ameesha Batheja, PhD, and Stephanie Turri, MS
Chapter 5 Pharmaceutical Labeling in the US................................................................................... 33
Cathleen O’Connell, PhD, MS, RPh, Susan Merchant, Zahra Martinez, PharmD, RPh,
and Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
Chapter 6 Patient Labeling in the US................................................................................................ 55
Cathleen O’Connell, PhD, MS, RPh, Christine Holzmueller, and Hoi Lam Chan, MPH,
BPharm (Hons)
Chapter 7 EU Product Information................................................................................................... 67
Nicole Beard, PhD, MSc
Chapter 8 Labeling of Human Drugs in Canada............................................................................... 79
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 9 Labeling of Nonprescription Human Drugs in Canada.................................................... 91
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 10 Plain Language Labeling................................................................................................. 101
Mary Speagle, RAC-US, RAC-CAN, RAC-Drugs
Chapter 11 Medical Device Labeling in the US. ...............................................................................107
Rita P. Francis, PhD, MS, MBA
Chapter 12 EU Labeling for Medical Devices and In Vitro Diagnostic Medical Devices................ 117
Nicole Beard, PhD, MSc