After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway

Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

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A US Food and Drug Administration proposed rule on “additional conditions for nonprescription use” comes more than 10 years after it introduced “novel switch” as a potential for making more drugs available OTC.

Publishing a proposed rule on 27 June wasn’t reached in a straight line and featured coining another term with...

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