Tag Archives: Pharmaceutical

New Edition of Pharmaceutical Compliance and Enforcement Answer Book Now Available

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PLI’s Pharmaceutical Compliance and Enforcement Answer Book 2015 is now available.  This 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, Pharmaceutical Compliance and Enforcement Answer Book 2015 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 2015 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations.

If you’d like to order Pharmaceutical Compliance and Enforcement Answer Book 2015, please email the PLI Library Help Desk or call 877-900-5291.

Pharmaceutical and Biotech Patent Law

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Release # 3 is now available for Pharmaceutical and Biotech Patent Law.  This treatise was reviewed by the New York Law Journal.  

Written by one of the country’s foremost patent law groups, this uniquely accessible reference provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge the validity of patents.

Readable enough for non-lawyers and non-scientists, Pharmaceutical and Biotech Patent Law shows you how to craft rock-solid patent applications for these inventions; partner with the government to bring patented inventions quickly to the marketplace; invalidate competitors’ patents by proving they fail to meet key requirements; protect against various forms of patent infringement; and successfully rebut charges that your clients are infringers. Included are detailed checklists that help you resolve especially thorny patent problems.

If your library is on standing order for this treatise, you can expect Release #3 to arrive soon.  If you’d like to order the release please email libraryrelations@pli.edu or call 877-900-5291. 

View a sample chapter here.