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FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.[ Price : $8.95]
FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.[ Price : $8.95]
FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.[ Price : $8.95]
FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.[ Price : $8.95]
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...[ Price : $8.95]
FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...[ Price : $8.95]
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.[ Price : $8.95]
FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.