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RAPS NY/NJ Chapter: First Amendment Considerations for Off-Label and Healthcare Economic Information
Loeb & Loeb LLP
345 Park Avenue New York, NY 10154
May 9, 2017
5:00 PM - 8:00 PM ET
2.00 RAC
  • List Price: $40.00
  • Member Price: $25.00
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In response to recent First Amendment jurisprudence, FDA is reviewing its policy strategies related to speech restrictions under the Food, Drug and Cosmetic Act. On a mission to balance “ongoing developments in science and technology, medicine, healthcare delivery, and constitutional law” with...

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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