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.
More from Compliance
• By
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.
• By
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.
• By
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.
• By
“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.
More from Policy & Regulation
• By
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
• By
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
• By
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.