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Prepare for Increased Enforcement of Off-Label Promotion Regulations

Published: September 2007 |  Pages: 328 |  Price:  $337  | ISBN:  978-1-60004-148-8  | Table of Contents

Brought to you by FDAnews, Prepare for Increased Enforcement of Off-Label Promotion Regulations is a management report that delivers solid strategies to keep you in compliance with off-label promotion laws.

Stay off the FDA’s “hit list” for good, and avoid millions of dollars in criminal and civil fines. Click here to order and you’ll access up-to-the-minute action tips that let you:

  • Minimize the risk of a government investigation into your sales and marketing practices
  • Find out — once and for all — precisely what off-label marketing is (and what it’s not)
  • Make sense of how these key laws relate to off-label marketing, including:
    • The False Claims Act
    • Anti-kickback laws
    • PDMA
    • And others
  • Know the latest off-label “red flags” that trigger unwanted government attention
  • Decipher the real-world implications behind recent court decisions and prosecutions
  • Get answers to your questions about qui tam actions:
    • What kind of threat do whistleblowers pose to you?
    • How can you head them off?

Criminal prosecution is no distant threat: 2005 and 2006 saw Eli Lilly and Schering-Plough ante up fines and disgorgement penalties as high as $435 million, enter into consent decrees and more.

Buy Now!
Don’t let it happen to you. Protect your product, your reputation and your future. Click here to order your copy today. Priced at $337 each, Prepare for Increased Enforcement of Off-Label Promotion Regulation is available in print or PDF format.

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Print Version

PDF Version
ISBN: 978-1-60004-148-8 ISBN: 978-1-60004-149-5
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