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Fraud-on-the-FDA As A Basis for A False Claims Act Lawsuit: Is It Dead Or Just Resting?

FDA Law Blog

Walsh — Legal doctrines can be like parrots. established by statute and case law. The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . By Jeffrey K.