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

 
• By Malcolm Spicer

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.

Timetable at the Central Station

The US Food and Drug Administration's latest Regulatory Agenda includes the planned publication by May 2020 of a notice of proposed rulemaking to allow firms to submit OTC new drug applications that incorporate extra-label information to help guide consumers' self-selection.

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