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.
More from Regulation
FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.
The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’
Biovanta’s products relieved symptoms faster than OTC drugs available under FDA monograph, according to clinical trial by brand owner Applied Biological Laboratories. Chief scientific officer Nazlie Latefi said the results were “greatest decreases to date in overall illness severity using clinically validated measures and comparable study design.”
Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.
More from Policy & Regulation
Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.
Latest regulatory goals update also includes April as target date for final rule on exemptions from IND clearance for clinical trials to evaluate food, dietary supplements or cosmetics and May for an NPRM would recognize N-acetyl-L-cysteine as a lawful dietary ingredient.
Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.