The Food and Drug Administration’s “additional conditions of nonprescription use” proposed rule for making more drug ingredients available OTC in the US portends introducing additional labeling obviously different from current options allowed by the agency.
Petros Pharma Introduces AI As ACNU Option In Research For OTC Switch Of Stendra ED Drug
Petros is first to introduce an OTC switch labeling tool which could be the next obvious step hiding in plain sight – AI, which wasn’t noted in FDA’s ACNU proposal and hasn’t previously been linked to a switch.
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“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.
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Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
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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.
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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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“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.
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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.