FDA Sketched NSURE Novel Switch Initiative In 2012
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA clarified parameters for novel switches of drugs to OTC status, 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.