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FDA publishes two final guidances to facilitate the timely start and finish of medical device post-approval studies and postmarket...[ Price : $8.95]
FDA says Bayer is making inadequate progress in a postmarket surveillance study of its Essure birth control device.[ Price : $8.95]
FDA grants Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with we...[ Price : $8.95]
Federal Register notice: FDA sets the medical device user fee rates and payment procedures for fiscal year 2023.[ Price : $8.95]
FDA clears an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System.[ Price : $8.95]
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2023.[ Price : $8.95]
FDA approves a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast canc...[ Price : $8.95]
Federal Register notice: FDA announces a 12/14 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Viatris Spec...