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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
The Second Circuit, New York’s federal court of appeals, this week issued its long-awaited decision in United States v. Caronia and vacated the conviction of a pharmaceutical sales representative for off-label promotion. In a...more
In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more