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4.00 RAC

FDA Law and Regulation

This course discusses the history of FDA’s authority, prohibited acts under the FD&C Act and enforcement action that FDA may utilize when individuals or corporations violate the FD&C Act. This course also provides insight into FDA regulatory reform and the initiatives FDA is undertaking to create a globally harmonized regulatory scheme for food, drug, device and cosmetic products.

4.00 RAC

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The US Food and Drug Administration (FDA) is authorized to regulate food, drug, device, biologic, veterinary, cosmetic and tobacco products under the Food, Drug and Cosmetic (FD&C) Act. FDA uses this authority to promote innovation of regulated products while protecting the public’s health by...

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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