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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.

The agency's list in the Department of Health and Human Services

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More from Regulation

More from Policy & Regulation

Digital Services Deliver Hemp, States Deliver Regulation With Congress Yet To Act

 
• By Malcolm Spicer

Four months into session, no bills have been introduced in Congress to authorize FDA to establish a regulatory pathway for the lawful use of hemp ingredients in products other than drugs or propose some other solution to the federal conundrum present since lawmakers in 2018 de-scheduled hemp.

Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Bayer Study: Self-Care Is Hardest For Those Who Need It Most

 
• By David Ridley

Being poor makes it more likely that you will suffer from self-treatable health conditions but it also means you will find it harder to take advantage of self-care solutions, finds a recently-published study by Bayer Consumer Health and IQVIA.