This edition of Quick Notes features FDA approval of Neuros Medical’s electrical nerve stimulation device, clearance for Clearmind Biomedical’s neuroendoscopy system for minimally invasive neurosurgery, approval for Illumina’s cancer biomarker…
Ophthalmology-focused biopharma EyePoint Pharmaceuticals received an FDA Warning Letter underscoring serious GMP violations at its Watertown, Mass., facility, mostly related to a one-time injection eye drug. Source: Drug Industry Daily
The FDA offers updated advice to medical device sponsors on how to use patient preference information (PPI) throughout the product lifecycle, in a new draft guidance. Source: Drug Industry Daily
This week, the FDA published eight medical device classifications — cardiovascular, dental (2), hematology and pathology, neurologic, ophthalmic, orthopedic and physical medicine. Final guidance was issued on nitrosamine impurities. The…
This edition of Quick Notes features announcements of UCB’s divestiture of its Chinese neurology and allergy business and collaborations between Bayer and NextRNA, Flagship Pioneering and Pfizer, and Adcendo and…
Richmond, Calif.-based Berkeley Biologics failed to file BLAs for several bone matrix products distributed to medical facilities nationwide and lacked proper screening for tissue donors, among other serious lapses cited…
The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels of nitrosamine impurities, in a new revised guidance. Source: Drug Industry Daily
This edition of Quick Notes features FDA clearances that expand the indications of a device to treat Type 2 diabetes, label changes that eliminate aspirin use for heart pump patients,…
This week, the FDA published modified a rule and issued final guidance on medical device voluntary malfunction reports. Source: Drug Industry Daily
This edition of Quick Notes features announcements of J&J’s acquisition of V-Wave, Paragonix Technologies’ sale to Getinge, Dupont’s purchase of Donatelle Plastics and Stryker’s deal to buy Vertos Medical. Source:…