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Woodcock Selects Deputy Director to Lead Office of New Drugs

[ Price : $8.95]

CDER director Janet Woodcock selects Office of New Drugs deputy director Peter Stein as permanent director of the Office.

Draft Guide on Blood Bacterial Rick Controls

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Bacterial Risk Control Strategies for Blood Collection Esta...

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

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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

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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

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

Mylan Expanding Valsartan Recall

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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.