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Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and...[ Price : $8.95]
Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will dis...[ Price : $8.95]
Philips Respironics recalls its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air...[ Price : $8.95]
FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 ...[ Price : $8.95]
FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility ci...[ Price : $8.95]
FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.[ Price : $8.95]
FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for tr...[ Price : $8.95]
FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.