Task p5y453db
Law Document / Contract AnalysisLivyra has scrapped the "Focus on What Matters" campaign. They intend to replace it with a new campaign advertising to the general population which states normal approved audio messages based on depression treatment in adults but is supplemented with images of happy children hugging their parents. Looking at the guidance from the FDA, "Guidance from FDA on Unapproved Uses.pdf", as well as case law such as US v. Caronia, "US v. Caronia, 703 F. 3d 149 - Court of Appeals, 2nd Circuit 2012.pdf", will Livyra be in violation of FDA regulations regarding off-label marketing?
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