Essentials of Healthcare Product Labeling

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Essentials of Healthcare Product Labeling

Table of Contents


Lead Editor

Cathleen O’Connell, RPh, MS, PhD

Product Description

Labeling is an essential part of drug, biologic and medical device approval and marketing. The first book on the topic, Essentials of Healthcare Product Labeling was written by regulatory professionals for regulatory professionals. This book presents details on all aspects of labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada. It also discusses the various targeted audiences for product labeling, including health authorities, prescribers and patients and how these audiences use the different labeling pieces. Those new to the field will find this an invaluable source of information and it also serves as an outstanding reference.

Who should buy this book?

This book is intended for the industry professional tasked with “doing the labeling” for a healthcare product or development candidate.

Published by RAPS © 2019. Hardcover. 169 pages. ISBN: 978-1-947-493-40-7.

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