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

 
• By Hannah Daniel

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

The new proposed rule was not developed in a straight line over the last several years. • Source: Shutterstock

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 pathway to make 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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More from Pathways & Standards

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