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FDA sends United Therapeutics a complete response letter declining to approve its oral treprostinil for treating pulmonary arteria...[ Price : $8.95]
FDA approves SpineSmiths VisuALIF Challenging Access Plate System, an extension to its anterior lumbar interbody fusion device to ...[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect September approval actions and sponsorship changes.[ Price : $8.95]
CDER deputy director for clinical science Bob Temple says his Center is interested in reviewing data from failed drug development ...[ Price : $8.95]
AdvaMed asks FDA for 60 additional days for comments on the agency report on strengthening the national system for medical device ...[ Price : $8.95]
FDAs Los Angeles District Office warns Alere about Quality System Regulation violations in its manufacturing of Triage cardiac mar...[ Price : $8.95]
Companies commenting on FDA data standards urge the agency to be consistent in standards and their application.[ Price : $8.95]
FDA clears the Sysmex XN-series hematology analyzers that include a test to help diagnose thrombocytopenia.