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3.00 RAC

Regulation of IVDs in the US

This course provides a basic overview of in vitro diagnostic medical devices with a focus on the US Food and Drug Administration (FDA) regulatory requirements.

3.00 RAC

  • List Price: $495.00
  • Member Price: $360.00

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In vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent...

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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