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Drger Medical Recalls Ventilators Due to Battery Problem

[ Price : $8.95]

Drger Medical recalls its Evita V500 Ventilator and Babylog VN500 Ventilator due to battery concerns.

Public Comments Sought on Safety Labeling Guidance

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Federal Register notice. FDA seeks public comment on a proposed collection of information regarding its requirements to make safet...

Committee Wants Info on FDA Warfarin Role

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The House Energy and Commerce Committee asks FDA to answer questions about its role in ensuring safety of patients taking Coumadin...

HHS, Others Seek New Human Subject Protections

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A 9/3 Federal Register notice from 16 federal agencies proposes changes to human subject protection rules for clinical research.

Sandoz Opposition Brief on Amgen Move to Delay Biosimilar

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Sandoz files an opposition brief urging the Federal Circuit Court of Appeals to deny an Amgen emergency motion for injunctive reli...

Great Basin Submits Multiplex Panel for FDA Clearance

[ Price : $8.95]

Great Basin Scientific files a 510(k) for its Staph ID/R Blood Culture Panel.

Flextronics China Inspection Finds Violations

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FDA warns Flextronics International about Quality System Regulation violations in its manufacturing of patient arrhythmia monitors...

Medtronic IDs Gene Causing Abnormal Heart Rhythms

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Medtronic says two studies have identified a gene associated with life-threatening abnormal heart rhythms. The studies evaluated g...

QS, MDR Issues Found at Cardiac Designs

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FDAs Dallas District Office warns Cardiac Designs about Quality System and Medical Device Reporting violations in its manufacturin...

Hartley Medical Center Pharmacy Cited

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A just-released FDA-483 details six observations from an inspection at the Hartley Medical Center pharmacy.