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Remote Assessments A Welcome Option For US FDA, But They’re Not Every Firm’s First Choice

 
• By Hannah Daniel

“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.

• Source: Shutterstock

Remote regulatory assessments aren’t the first choice for everybody in dietary supplement manufacturing, even though those firms have that as an option to regulatory inspectors visiting their facilities.

RRAs, which the Food and Drug Administration turned to during travel restrictions imposed at the onset of the novel coronavirus pandemic in 2020, won’t replace in-person inspections or change the “core requirements of

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US Tariffs Pose ‘Existential Threat’ To EU Medical Devices Industry

 
• By David Ridley

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Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.