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FDA warns Britains Rocket Medical about Quality System violations in its manufacturing of IVF devices.[ Price : $8.95]
FDAs Philadelphia District Office warns OraWell USA about manufacturing an HIV test kit without premarket approval or an IDE.[ Price : $8.95]
FDA clears an Accuray 510(k) for the Dose Control System (DCS), a new feature for the company's TomoTherapy Radiation System to im...[ Price : $8.95]
Industry and patient/consumer groups provide feedback to FDA on the negotiated Prescription Drug User Fee Act reauthorization prop...[ Price : $8.95]
Cell Therapeutics resubmits its pixantrone NDA to FDA, responding to a complete response letter and recommendations from the CDER ...[ Price : $8.95]
Eli Lilly withdraws its sepsis drug Xigris (drotrecogin alfa activated) after clinical trial results from a study called PROWESS-...[ Price : $8.95]
CDRH asks the Circulatory System Devices Panel for input on the safety of Medtronics Cardiac Ablation System for which the company...[ Price : $8.95]
Seven organizations ask HHS to move quickly to implement the Physician Payments Sunshine provision of the healthcare reform law.