Practising Law Institute (PLI) has announced the release of their newest title, . This valuable new guide provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. Pharmaceutical Compliance and Enforcement Answer Book 2014
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,
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: Pharmaceutical Compliance and Enforcement Answer Book 2014
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
please email the Pharmaceutical Compliance and Enforcement Answer Book 2014, Library Relations Help Desk or call 877-900-5291.
In November 2013, PLI updated the following Treatises:
If you are on standing order for any of these titles, the releases have already been shipped. If you would like to place an order, please email
PLI Library Relations or call 877-900-5291
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Listed below are the
PLI Course Handbooks that were published in April 2013:
Corporate Law and Practice
Litigation and Administrative Practice
New York Practice Skills
Tax Law and Estate Planning:
If you have any questions or would like to order a title, please email the
Library Relations Help Desk or call 877-900-5291.
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In December 2012, the following PLI Treatises were updated:
If you are on standing order for any of the above titles, these releases have already been shipped. If you would like to place an order, please email
firstname.lastname@example.org or call 877-900-5291.