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Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement

Published: February 2008 |  Pages: 102 |  Price:  $337  | ISBN:  978-1-60004-180-8  | Table of Contents

Specifically geared to devicemakers, discover how to comply with off-label promotion requirements in the management report brought to you by FDAnews — Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement. Place your order today.

This comprehensive report delivers timely how-to tips, case studies, best practices and more that let you:

  • Access 10 targeted compliance strategies for off-label promotions
    • Specifically addresses the differences between pharma and device — from a “government prosecutor perspective”
  • Avoid foot-in-mouth marketing comments —
    • Six dos and three don’ts for communicating with medical professionals
  • Know the three types of off-label communications that aren’t violative and what actions your staff must avoid in these situations

Are Your Off-Label Promotions Raising a Red Flag?
Find Out, With Sample Warning Letters and More

Plus, when you order Device Off-Label Promotion, you’ll discover how to sidestep warning letters, avoid devastating media meltdowns and even criminal prosecution, as you:

  • Dramatically improve your compliance program, by including the four critical elements included in your report
  • Fortify your sales force and promotional compliance programs with best practices for training and documentation
  • Get hands-on warning letter experience without any of the damaging effects — actual sample letters detail violations for:
    • Website marketing language (Eidam Diagnostics, Tyco Healthcare/Kendall)
    • CDs and information packets (Synthes)
    • Misbranding (Eidam Diagnostics, Tyco Healthcare/Kendall)
    • Data collected in surveys (Synthes)
    • Plus other related violations
  • Access instant answers to common questions about compliance

Buy Now!
Specifically geared to devicemakers, Device Off-Label Promotion: Case Studies to Prepare for Increased Enforcement is available for $337, in print or PDF format.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

Interested in Electronic Multi-user Access?
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable.

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Print Version

PDF Version
ISBN: 978-1-60004-180-8 ISBN: 978-1-60004-181-5
PDF will be available to download after your purchase is complete.