TreatiseAnswer Book


Pharmaceutical Compliance and Enforcement Answer Book (2019 Edition)

 by Howard L Dorfman
 Copyright: 2019

 Product Details >> 

Product Details

  • ISBN Number: 9781402433559
  • Page Count: 0
  • Number of Volumes: 1

Now available for pre-order.

Pharmaceutical Compliance and Enforcement 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, this resource discusses:

  • 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 provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
Your purchase will also sign you up for “Upkeep Service,” whereby you will receive future automatic shipments of updates, new editions and supplements to this edition, as they become available, for a 30-day preview. Updates, new editions and supplements published within 90 days of your purchase will be issued free of charge; all other updates will be subject to an additional charge if kept beyond the preview period, invoiced at the time of delivery. This service will continue until canceled by you at any time. See here.

  • twitter
  • LinkedIn
  • YouTube
  • RSS

All Contents Copyright © 1996-2019 Practising Law Institute. Continuing Legal Education since 1933.

© 2019 PLI PRACTISING LAW INSTITUTE. All rights reserved. The PLI logo is a service mark of PLI.