The US Food and Drug Administration’s path to a final rule on allowing OTC switches with labeling extending to information accessed digitally began in 2012 when it announced its consideration of a “new paradigm” for nonprescription drug approvals, particularly formulations indicated for chronic conditions.
‘New Paradigm’ For US OTC Switches Dawns After More Than 12 Years With ‘ACNU’ Final Rule
FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
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HBW Insight catches up with Maxwellia CEO Anna Maxwell to discuss her company's journey so far, and what she sees as the opportunities for Rx-to-OTC switch in UK women's health and beyond.
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Advercheck managing director James Walmsley talks to HBW Insight about the challenges facing consumer health companies today as they move away from the prescription medicines sector and its pipeline of switchable ingredients towards self-care and prevention.
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Vitawell seeking to empower consumers left confused by the vast array of dietary supplements available to them in the UK.
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Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.
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Round up of the latest appointments: PAGB names vice presidents; Activ'Inside gets first US head; EMA elects management board chair.