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GREENBELT, Md. - (Mealey's) Former GlaxoSmithKline vice president and associate general counsel Lauren Stevens was acquitted by directed verdict May 10 of charges of obstructing a Food and Drug Administration investigation into the off-label promotion...

AUSTIN, Texas -- Johnson & Johnson subsidiary Janssen LLP said Jan. 19 that it has agreed to pay $158 million to settle claims by Texas that it defrauded the Medicaid program through its off-label promotion of the atypical antipsychotic drug Risperdal...

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance...

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending...