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FDA Sketches NSURE Novel Switch Initiative In 2012

This article was originally published in The Tan Sheet

Executive Summary

FDA clarified parameters for novel switches, including protecting innovators from potentially unfair generic competition and stating that a behind-the-counter class is not being considered, but the year ended without clear signals on what could be the potential first novel switch candidate and when FDA expects to propose regulatory changes to facilitate switches under conditions of safe use.

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