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Pharmaceutical Compliance and Enforcement Answer Book 2016
By Howard L. Dorfman (editor)
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Bibliographic Detail
Publisher Practising Law Inst
Publication date June 7, 2016
Pages 586
Binding Paperback
Book category Adult Non-Fiction
ISBN-13 9781402426131
ISBN-10 1402426135
Dimensions 0 by 6 by 9 in.
Original list price $295.00
Summaries and Reviews
Amazon.com description: Product Description: PLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

In an easy Q&A format,
Pharmaceutical Compliance and Enforcement Answer Book 2016 describes:

  • 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 2016 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations.

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Paperback
Book cover for 9781402426131
 
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from Practising Law Inst (June 7, 2016)
9781402426131 | details & prices | 586 pages | List price $295.00
About: PLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

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