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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Primary mode of action: FDA lengthens the deadline for receiving stakeholder comments on the agency's proposed rule defining "mode of action" and "primary mode of action" to Aug. 20, following AdvaMed request for a 60-day extension, according to a June 24 Federal Register notice. FDA issued the proposed rule clarifying the mechanism for assigning jurisdiction of combination products May 7 (1"The Gray Sheet" May 10, 2004, p. 12). Comments initially were due July 6...
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