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FDA issues a draft guidance with recommendations for establishing clinical effectiveness for drugs to treat male hypogonadotropic hypogonadism associa...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.
CDER director Janet Woodcock says there remains a need for improvements in sanitary conditions in drug compounding facilities.
Bloomberg columnist Max Nisen says FDA commissioner Scott Gottlieb is not always doing what industry expected he would do.
FDA issues a draft guidance on Information Requests and Discipline Review Letters Under GDUFA that outlines how such letters will be used during the A...