Paul E. Kalb, MD, is a former global practice leader, healthcare and FDA Group, for Sidley Austin LLP
Where Caremark Meets Park: A New Era of Regulatory Compliance and Criminal Liability
The Caremark and Park doctrines require directors and managers of life sciences companies to address regulatory compliance proactively and vigorously.
In DOJ Crosshairs: Rethinking Commission-Based Deals With Independent Contractors
Pharma companies should review their commission-based compensation arrangements with independent contractors to address enforcement risk under the Anti-Kickback Statute, in light of recent Department of Justice enforcement.
Under Federal Fire
Companies that fail to comply with regulatory guidelines make easy targets for investigators.
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