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3.00 RAC

Medical Devices: Advertising and Promotion in the US

Included are guidelines on the information needed for a regulatory review of medical device advertising, methods used to identify claims in promotional materials and how to evaluate evidence to substantiate various types of claims.


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3.00 RAC

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This course provides information on the US agencies that regulate medical devices, their enforcement tools, as well as strategies to avoid enforcement actions. Included are guidelines on the information needed for a regulatory review of medical device advertising, methods used to identify claims in...

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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