Overview

Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

In an easy Q&A format, this resource discusses:

  • The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency
  • A facility's rights and compliance obligations during an inspection by the agency
  • How to best evaluate a company's potential of being in violation and what to do to mitigate those risks
  • What advertising and promotion of prescription drugs is permitted
  • How product liability issues overlap with FDA enforcement initiatives
  • When criminal prosecution is used as part of the regulatory enforcement effort
Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
Publication Date: July 2019
ISBN: 978-1-4024-3355-9
Page Count: 800 pages
Number of Volumes: 1
Contents