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Hamburg: Neither U.S. Nor EU Device Regulation Has It Completely Right

This article was originally published in The Gray Sheet

Executive Summary

During her final public appearance at the National Press Club, outgoing FDA Commissioner Margaret Hamburg defended her tenure and said she was leaving a stronger FDA than the one she inherited. Asked about the agency's device regulatory process, she said she didn't know if FDA or Europe had struck the right balance but said more work needs to be done.

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