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Criminal Prosecution › Federal Food Drug and Cosmetic Act (FFDCA) › Off-Label Use

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Mintz - Health Care Viewpoints on

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

Arnall Golden Gregory LLP

Officer/Director Liability for Violations of the US Federal Food, Drug, and Cosmetic Act

Arnall Golden Gregory LLP on

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more

Foley Hoag LLP

Second Circuit Vacates Conviction Against Sales Representative for Off-Label Promotion

Foley Hoag LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

Skadden, Arps, Slate, Meagher & Flom LLP on

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

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