The Food and Drug Administration has shown in recent actions that hidden, substandard facilities continue to manufacture adulterated drugs available in the US, violations the agency is pressing Congress for authority for stronger ability to identify those facilities.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
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HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.
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A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.
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Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.
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“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.
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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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“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”
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“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.