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21st Century Cures Criticism Starts To Flow In

This article was originally published in The Gray Sheet

Executive Summary

The first draft of a 21st Century Cures bill aimed at bringing faster cures to patients is not ready for prime time and has serious flaws, say two key Democrats on the House Energy and Commerce panel. And regulatory insiders and consumer advocates who are looking more closely at the device reform proposals in the draft worry that several of them would overly constrain FDA reviewers.

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