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The Verdict Is In: SuperValu Wins at Trial Despite Knowingly Submitting False Claims

In 2023, we wrote about the Supreme Court’s decision in United States ex. rel. Schutte v. SuperValu Inc. interpreting the False Claims Act’s (FCA) scienter standard to require inquiry into a defendant’s subjective knowledge....more

FDA Finalizes ‘Instructions for Use’ Guidance on Patient Labeling for Drugs and Biologics

As companies begin planning for the upcoming year, attorneys who sit on promotional review committees should consider the significant guidance published by the U.S. Food and Drug Administration (“FDA”) and update process aids...more

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