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