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FDA Criticizes Cardiac Science Problem Announcement

[ Price : $8.95]

FDA says that Cardiac Science has not adequately communicated and addressed potential problems with two models of automated extern...

FDA Clears Boston Scientific Esophageal Stent

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FDA clears a Boston Scientific 510(k) for the WallFlex Fully Covered Esophageal Stent.

FDA Revises Peramivir IV Dosing Recommendations

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FDA publishes revised Peramivir IV dosing recommendations for several groups of patients.

FDA Pushes Preventing Endoscope Cross-contamination

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FDA says it has received recent reports of processing errors with flexible endoscopes and cautions that proper procedures must be ...

FDA Enforcement Sweep Targets 136 Web Sites

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FDA says its participation in the International Internet Week of Action included targeting 136 Web sites and issuing 22 Warning Le...

FDA Clears Spineology Screw System

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FDA clears a Spineology 510(k) for the Capture Facet Screw System, intended for use in percutaneous implantation.

FDA OKs Pharmacia & Upjohn sNADA for Heifer Feed

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Federal Register Final rule: FDA approves a Pharmacia & Upjohn supplemental NADA for increased dose levels for two-way combination...

Guidance on Blood Safety, Supply with H1N1 Pandemic

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Federal Register Notice: FDA releases a draft guidance on recommendations for assessing blood donor suitability, blood product saf...

FDA Complete Response on Rituxans Use in Leukemia

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Genentech and Biogen Idec receive an FDA complete response letter on Rituxan (rituximab) and its combination use with fludarabine ...

AstraZeneca Files NDA for Plavix Competitor

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AstraZeneca files an NDA for Brilinta (ticagrelor), an investigational oral antiplatelet treatment for reducing major adverse card...