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Consumers Groups Praise FDA Draft ‘Emerging Signals’ Plan; Industry Continues Opposition

This article was originally published in The Gray Sheet

Executive Summary

FDA’s proposed decision to start giving the public early warning of device risks in its “Emerging Signals” draft was praised by consumer and patient groups in March comments, but industry complained that the agency has no authority to issue early warnings. Companies say the communications will confuse patients and gives firms no chance to review the message FDA sends out about product risks.


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