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SuperValu and Executive Health Resources: What to Know About the FCA Following the 2023 Term

As we take stock of the Supreme Court’s 2023 term, two landmark decisions shift our understanding of scienter and government intervention as it relates to the False Claims Act (“FCA”), 31 U.S.C. § 3729. First, on June 1,...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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