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FDA Clears Meridian Congenital Cytomegalovirus Assay

[ Price : $8.95]

FDA clears a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test.

Info Collection Extension for Environmental Impact Considerations

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension entitled Environmental Impact Considerations.

FDAs New Real-World Evidence Strategic Framework

[ Price : $8.95]

FDA commissioner Scott Gottlieb announces release of a strategic framework for advancing use of real-world evidence in 2019.

Medtronic Ventilator Field Correction is Class 1

[ Price : $8.95]

FDA says a Medtronic field corrective action for its Puritan Bennett 980 ventilator series is a Class 1 recall.

In Vitro Companion Device Labeling Guidance

[ Price : $8.95]

FDA issues a guidance on class labeling for companion diagnostic products for classes of oncology therapeutic products.

Mylan Expanding Valsartan Recall

[ Price : $8.95]

FDA says Mylan expands its recall of several types of valsartan-containing products.

FDA New Approach to Regulating In Vitro Tests

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FDA commissioner Scott Gottlieb and other agency leaders call for a new unified approach to regulation of in vitro clinical tests.

POPS! Blood Glucose Monitoring Device

[ Price : $8.95]

FDA clears a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system.

Tris Pharma Recalls Infant Ibuprofen

[ Price : $8.95]

Tris Pharma recalls three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the p...

FDA Wants Food Handler Antiseptic Product Info

[ Price : $8.95]

FDA opens a docket for stakeholder comments and data on the safety and effectiveness of antiseptic products intended for use in co...