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

Executive Summary

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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Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Facilitating More OTC Switches In US Graduates To Regulatory Plan On FDA’s Unified Agenda

For first time rules for novel switches and OTC hearings aids are parts of “significant regulatory actions” in agency’s plans. Information is added in Unified Agenda items explaining likely benefits and costs from the changes.

FDA Plans To Publish 'Novel' OTC Switch NPRM In May 2020

Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.

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