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Revised False Claims Act Is A Minefield For Manufacturers, Lawyers Say

This article was originally published in The Gray Sheet

Executive Summary

Off-label promotion lawsuits against device and drug companies may be easier to bring under recent changes to the federal False Claims Act

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QUOTED. 25 November 2020. Ricki Chase.

The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.

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