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Fundamentals of International Regulatory Affairs, Third Edition

This third edition is updated with developments through 2016 and delves more deeply into specific countries and regions than previous editions. It covers the full gamut of regulated healthcare products.

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Fundamentals of International Regulatory Affairs, Third Edition, has been revamped and updated to reflect changes in the three years since the second edition was published. More than two dozen authors from around the world contributed to the new book, adding new information on all areas of the...

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Fundamentals of US Regulatory Affairs, Eighth Edition

Table of Contents

Section I: General Information
Chapter 1 FDA and Related Regulatory Agencies
Chapter 2 History of Food, Drug and Cosmetic Law
Chapter 3 Overview of Drug, Biologic and Device Regulatory Pathways
Chapter 4 FDA Communications and Meetings
Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings
Chapter 6 Crisis Management
Chapter 7 Health Technology Assessment
Chapter 8 Good Laboratory Practice Regulations
Chapter 9 Clinical Trials: GCPs, Regulations and Compliance
Chapter 10 Current Good Manufacturing Practice and Quality System Design