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09/30/2021
FDA Clears Caretaker Medical’s Wireless Platform for Continuous Noninvasive Blood Pressure and Hemodynamic Monitoring
Caretaker Medical, a pioneer in wireless “beat by beat” continuous, non-invasive, advanced patient monitoring, announced U.S. Food and Drug Administration (FDA) clearance of the company’s next-generation VitalStream™ wireless blood pressure and hemodynamic monitoring platform. Continuous monitoring of blood pressure is of great importance to detect and treat dynamic changes. Traditionally, blood pressure is measured intermittently …
09/20/2021
BASF Adopts BrightSpec’s Broadband MRR Technology for Structural Elucidation
BrightSpec announced the start of operation of a broadband Molecular Rotational Resonance spectrometer at BASF’s research center in Ludwigshafen, Germany. BASF will utilize MRR spectroscopy for the concise structure elucidation of organic compounds where isomerism is an underlying question. Major applications comprise stereochemical analysis, including chirality, defining the composition of mixtures without purification, and the …
08/12/2021
FDA Solicits Feedback on Drug Products Approved Under Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments
The FDA has established a public docket to solicit comments on several issues related to FDA’s regulation of certain drug products approved under abbreviated new drug applications before the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Amendments. Because these Pre-Hatch-Waxman ANDAs (PANDAs) were submitted under …