An Illinois OTC ophthalmic drug manufacturer failed to convince the Food and Drug Administration it was keeping contaminants away from a sterile processing line and was advised to conduct a comprehensive evaluation of the effectiveness of its environmental monitoring.
Sloppy Sterility Seen At US OTC Ophthalmic Firm
Mexican Sanitizer Maker Also Warned About Sterile Conditions, Halts Production
Sterling Pharmaceutical’s Restricted Access Barrier Systems “permitted access to the processing line … without the design of rigid wall enclosures,” FDA says. Eksa Mills makes cleaning solutions with the same equipment in same facility and didn’t maintain written cleaning procedures or equipment use logs.
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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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Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
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FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
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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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“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.