Simplifying Global Compliance
Navigating Off-Label Device Promotion: How Will the FDA Settlements Impact Devicemakers?
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Navigating Off-Label Device Promotion
How Will the FDA Settlements Impact Devicemakers?
The FDA has historically taken a firm, restrictive stance on communications about off-label uses of products. But, the agency’s position has become increasingly uncertain as the courts address the subject of freedom of “commercial speech.”
Several pharma companies have made headway with the FDA — but, what is view from the device side of the industry-agency gap?
Will the recent decisions in the Amarin and Pacira cases open the door for devicemakers to broaden their communications?
How are device companies faring in their own legal battles with the agency?
Find out in the management report Navigating Off-Label Device Promotion. The report will cover the following:
- Current device industry efforts to expand off-label communications
- What the Amarin settlement really means for devicemakers
- When does distributing information become promotion?
- Essential dos and don’ts for distributing scientific articles
- Why the “safe harbor” turned out not to be so safe
- How and why off-label rules have evolved from 2008 to the present day
- Pivotal court cases and how they’ve shaped the law
Devicemakers need to keep up with developments that may impact their sales efforts.
Order your copy of Navigating Off-Label Device Promotion: How Will the FDA Settlements Impact Devicemakers? today and stay on top of the FDA’s latest rules on what speech is and is not protected.
Order Your Copy Today
PDF Edition — $397
Who Will Benefit
- Compliance officers
- Consultants/service providers
- Executive management
- General/corporate counsel
- Manufacturing directors and supervisors
- Regulatory/legislative affairs professionals
- Risk management specialists
- Sales/marketing personnel
- Strategic planning and business development staff
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