Sterilmed begins a Class 1 recall of its Reprocessed Agilis Steerable Introducer Sheath due to an improper seal of the sheath hub.
FDA accepts for review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treat...
CDER Office of Prescription Drug Promotion sends Vanthi (Newtown, PA) a Warning Letter objecting to a medical conference marketing panel for its Lomai...
FDA says it will require a new Warning and other steps to inform patients and healthcare professionals about the risk of gadolinium retention in the b...
FDA warns Mexicos Prosana Distribuciones about CGMP and other violations in its production of finished pharmaceuticals.
FDA warns Fresenius Kabi Oncology about CGMP violations in its manufacturing of finished pharmaceuticals at a facility in India.
FDA issues a draft guidance with recommendations for establishing clinical effectiveness for drugs to treat male hypogonadotropic hypogonadism associa...
FDA issues its quarterly update on the status of projects under CDERs Data Standards Program Board.