An Evolving Approach to Enforcement in the Life Sciences Sector
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This program presented by Avia Dunn, counsel at Skadden, Arps, Slate, Meagher & Flom LLP, and Alexandra Gorman, counsel at Skadden, Arps, Slate, Meagher & Flom LLP, will explore recent enforcement trends against pharmaceutical and medical device manufacturers by the government's primary enforcers: (1) DOJ; (2) FDA; and (3) HHS-OIG. This course will analyze the types of civil and criminal cases the government is choosing to prosecute, examine trends in FDA enforcement, including DOJ's enforcement strategy regarding off-label, and explore the evolution of OIG's use of Corporate Integrity Agreements.
Review recent enforcement actions
Identify recent enforcement trends
Discuss compliance and risk management considerations to address the DOJ's and FDA's evolving approach to enforcement
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