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Global Medical Device Regulations, Second Edition

  • Compiles the information about international medical device regulation from Fundamentals of Regulatory Affairs series into a single volume: Global Medical Device Regulations, Second Edition
  • Provides a focused look at the complexities of regulatory on an international level

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For regulatory professionals working on international product development, rely on the robust resources in Global Medical Device Regulations, Second Edition. Featuring chapters compiled from RAPS’ Fundamentals of Regulatory Affairs series, this volume takes you from introductory information about...

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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