False Claims Act Liability A Guide for Drug and Device Manufacturers
Liability risk isn’t limited to illegal activities like paying kickbacks or bribing officials. Off-label promotion, adverse event reporting and even basic GMP issues can trigger an FCA action.
And the interim final rule from the Department of Justice virtually doubles penalties for FCA violations.
The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen.
You will learn:
What kinds of actions can lead to False Claims Act charges
New minimum and maximum penalty amounts
The significance of recent legal cases regarding off-label promotion and how they relate to FCA liability
The concept of “implied certification” and how it can be used against drug and devicemakers
What part whistleblowers play in FCA litigation
Non-monetary penalties that can be applied
With penalties typically in the millions — even billions — of dollars you can’t afford to not be in compliance. Order your copy of the False Claims Act Liability management report today.
PDF Edition — $397
Who Will Benefit
Regulatory affairs and compliance staff
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