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3.00 RAC

Regulation of Generic Drugs in the US

This course addresses the legal and regulatory structure for generic drugs in the US in an immersive experience designed for new and experienced professionals alike.

3.00 RAC

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

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The generic regulatory environment is complex. This course organizes information provided by FDA and dives into greater detail for an immersive experience designed to bring new professionals up to speed and fill knowledge gaps for more experienced professionals. Learn about generics from the...

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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