New Book: Pharmaceutical Compliance and Enforcement Answer Book 2014

pharm compliance AB 2014Practising Law Institute (PLI) has  announced the release of their newest title, Pharmaceutical Compliance and  Enforcement Answer Book 2014. This valuable new guide provides a  comprehensive overview of the regulatory issues faced by the different  participants in the pharmaceutical industry.

Howard L. Dorfman, Vice President and General  Counsel at Ferring Pharmaceuticals Inc, served as editor to this valuable new  guide. His years of experience in FDA regulatory law make this new title a  must-have addition to every practicing attorney’s library.

In an easy-to-read Q&A format, Pharmaceutical Compliance and  Enforcement Answer Book 2014 is a roadmap filled with practical  suggestions to help the reader navigate his or her way to effective compliance  with FDA pharmaceutical regulations. The book clearly details:

  • 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

If you’d like to order Pharmaceutical Compliance and  Enforcement Answer Book 2014, please email the Library Relations Help Desk or call 877-900-5291.

 

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