FDA clears an IsoRay 510(k) for its GammaTile brachytherapy technology that uses proprietary Cesium-131 seeds within customizable collagen-based carri...
New Jersey Democrat Frank Pallone says the House Energy and Commerce Committee should hold a hearing on drug company efforts to use the FDA REMS proce...
FDA clears an Oculocare Medical 510(k) for Alleye, a mobile medical software application indicated for detecting and monitoring age-related macular de...
FDA warns Chinas Foshan Jinxiong Technology about CGMP violations in production of finished pharmaceuticals.
Federal Register notice: FDA makes available a draft guidance entitled Indications and Usage Section of Labeling for Human Prescription Drug and Biolo...
Federal Register notice: FDA seeks comments on a information collection extension for General Licensing Provisions; Section 351(k) Biosimilar Applicat...
FDA Review posts product approval summaries for the week ending 7/6/2018.