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,…