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Fundamentals of US Regulatory Affairs, 10th Edition

This is the go-to resource of regulatory information on all FDA-regulated products including drugs, biologics, medical devices, foods, cosmetics and veterinary products. It also includes general information applicable across product lines.

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This 10th edition of Fundamentals of US Regulatory Affairs presents information covering all lifecycle stages of regulated healthcare products. More than 50 authors contributed to the content, which is current through May 2017. New chapters in this edition include preclinical and clinical chapters...

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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