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FDA clears a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test.[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension entitled Environmental Impact Considerations.[ Price : $8.95]
FDA commissioner Scott Gottlieb announces release of a strategic framework for advancing use of real-world evidence in 2019.[ Price : $8.95]
FDA says a Medtronic field corrective action for its Puritan Bennett 980 ventilator series is a Class 1 recall.[ Price : $8.95]
FDA issues a guidance on class labeling for companion diagnostic products for classes of oncology therapeutic products.[ Price : $8.95]
FDA says Mylan expands its recall of several types of valsartan-containing products.[ Price : $8.95]
FDA commissioner Scott Gottlieb and other agency leaders call for a new unified approach to regulation of in vitro clinical tests.[ Price : $8.95]
FDA clears a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system.