FDA Related News

Federal Register

Draft Guide on Blood Bacterial Rick Controls

Federal Register notice: FDA makes available a draft guidance entitled Bacterial Risk Control Strategies for Blood Collection Establishments and Trans...

Medical Devices

FDA Clears Meridian Congenital Cytomegalovirus Assay

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

Federal Register

Info Collection Extension for Environmental Impact Considerations

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

Human Drugs

FDAs New Real-World Evidence Strategic Framework

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

Medical Devices

Medtronic Ventilator Field Correction is Class 1

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

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

Human Drugs

Mylan Expanding Valsartan Recall

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

Medical Devices

FDA New Approach to Regulating In Vitro Tests

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

Medical Devices

POPS! Blood Glucose Monitoring Device

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

Human Drugs

Tris Pharma Recalls Infant Ibuprofen

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