Practising 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.