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Larger Personalized Medicine Trials Needed

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Oncologic Drug Advisory Committee panelists say companies may need to do larger clinical trials to demonstrate that they can use g...

FDA OKs New Labeling for Acetadote

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FDA approves updated labeling for Cumberland Pharmaceuticals Acetadote injection, an intravenous treatment for acetaminophen overd...

FDA Paying Company to Predict Heart Events

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FDA says it has contracted with Entelos for computer-simulated analysis of cardiovascular adverse events.

Woodcock Predicts Slow, Strong Gains from Sentinel System

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CDER director Janet Woodcock tells stakeholders FDAs planned Sentinel system for accessing and sharing diverse health databases wi...

Guide on Companion Animal Anesthetic Products

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Federal Register Notice: FDA releases a draft guidance on anesthetics for companion animals.

Info on Blood Establishments Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on blood establishment registration and product listing to...

Comments Sought on Export Requirements

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Federal Register Notice: FDA seeks comments on information collection requirements imposed on firms exporting FDA-regulated produc...

Appeals Court Reverses Drug Supply Order

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A federal appeals court says PTC Therapeutics does not have to provide an experimental drug to a 16-year-old muscular dystrophy pa...

Abbott Begins New Trial for Xience Stent

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Abbott says it has begun a study called SPIRIT Small Vessel, a clinical trial evaluating a 2.25 mm size of the Xience V Everolimus...

FDA Clears Peak Surgery System

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FDA clears a Peak Surgical 510(k) for the Peak Surgery System.