Off-Label Drug Promotion after Amarin What Does the FDA Settlement Mean?
The FDA has historically taken a firm, restrictive stance on drugmakers’ communications about off-label uses of their products. But, the agency’s position has become increasingly uncertain as the courts address the subject of freedom of “commercial speech.”
Now with the FDA settlement agreement with Amarin, other drugmakers are wondering what this means for them. Is this an “Amarin only” issue or does it have broader implications?
Find out in the management report Off-Label Drug Promotion after Amarin. The report will cover the following:
How and why the rules have evolved from 2008 to the present day
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
Order your copy of Off-Label Drug Promotion after Amarin: What Does the FDA Settlement Mean? today and stay on top of the FDA’s latest rules on what speech is and is not protected.
PDF Edition — $397
Who Will Benefit
Manufacturing directors and supervisors
Regulatory/legislative affairs professionals
Risk management specialists
Strategic planning and business development staff
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