FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.
FDA says it will receive comments until 2/28 on a draft guidance on the possibility for cancer drug sponsors and FDA to prepare a joint briefing docum...
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for the U.S. market.
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.
FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management System.
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.
