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Industry Attorneys Criticize FDA’s Emerging Signals Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

A recent draft guidance from FDA establishing a process for issuing early public warnings of possible safety risks linked to devices is raising the hackles of industry attorneys and advocates who say the warnings could confuse patients, lead them to avoid appropriate use of devices and increase the likelihood of frivolous lawsuits.


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FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks





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