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AdvaMed and other device stakeholders urge the Centers for Medicare & Medicaid Services to overhaul how it covers new device techn...[ Price : $8.95]
Boston Scientific recalls (Class 1) its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that created an in...[ Price : $8.95]
A new Form FDA-483 cites significant GMP issues at the plant that makes Regenerons Eylea HD (aflibercept), delaying review of two ...[ Price : $8.95]
FDA clears a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically...[ Price : $8.95]
FDA is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information...[ Price : $8.95]
FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne ...[ Price : $8.95]
FDA publishes a guidance with recommendations for 510(k) animal studies for dental bone grafting material devices.[ Price : $8.95]
FDA publishes a draft guidance with recommendations for approaches to assessing overall survival in oncology clinical trials.