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Fundamentals of US Regulatory Affairs, Ninth Edition

  • 41 chapters by 49 expert authors
  • Enhanced matrix that clearly explains current regulations
  • New chapters on regulatory strategy, regulating regenerative medicines and user fees

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* Fundamentals of US Regulatory Affairs, 10th Edition available July 2017

Knowledge is the driving force of success in regulatory. Whether you are navigating the world of the US Food and Drug Administration or working in pharmaceuticals, biotech or medical devices, you need access to the most...

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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