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Pharmaceutical Compliance and Enforcement Answer Book (2019 Edition)

 by Howard L Dorfman
 
 Copyright: 2019

 Product Details >> 

Product Details

  • ISBN Number: 9781402433559
  • Page Count: 0
  • Number of Volumes: 1
  •  

Now available for pre-order.

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.
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