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FDA grants orphan drug status to CMC Contrast AB for its liver-specific contrast agent for diagnostic MRI for detecting liver lesi...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on information collection in FDAs Importers Entry Notice.[ Price : $8.95]
Federal Register Notice: FDA is reopening the comment period Draft Guidance for Industry on Bioequivalence Recommendations for Flu...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period on a draft guidance on the generic drug user fee amendments of 2012.[ Price : $8.95]
Federal Register Notice: FDAs Risk Communications Advisory Committee will meet 12/17 to discuss new methods for communication risk...[ Price : $8.95]
Federal Register Notice: CDER and CBER announce a pilot project to evaluate the Clinical Data Interchange Standard Consortium Subm...[ Price : $8.95]
FDA clears a BioMedical Enterprises 510(k) for an upgrade to its HammerLock Nitinol Intramedullary Fixation System.[ Price : $8.95]
FDA clears an Elekta 510(k) for the Monaco 5, the latest version of its Monaco treatment planning system.