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Review Period Set for Teijin Pharmas Uloric

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Federal Register Notice: FDA determines the regulatory review period for Teijin Pharmas Uloric for the purpose of patent extension...

Abbott Recalls 1 Prism HIV O Plus Lot

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Abbott recalls one lot of its Prism HIV O Plus assay due to customer complaints of calibration failures.

FDA Says Hospira Symbiq Pump Recall is Class 1

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FDA says a Hospira recall of its Symbiq infusion pumps that may fail to detect air in line at the end of an infusion is a Class 1 ...

Scharmann Gives Corrigan 2 Years as ACRA

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Consulting editor John Scharmann reviews the announcement of Dara Corrigan as FDAs new top cop, notes the accuracy of a prediction...

Engerix and Havrix Syringes May Contain Latex

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GlaxoSmithKline says its Havrix and Engerix-B hepatitis vaccine syringes may contain latex.

Smallest Drug Firms Having More Approval Success

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A Tufts Center for the Study of Drug Development Impact Report says that smaller drug companies are experiencing more approval suc...

FDA Clears Spinal Plating System

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FDA clears an Aesculap Implant Systems 510(k) for the S4 Cervical Occipital Plating System, intended for use in promoting spinal f...

FDAers Caution on Reading Too Much Into Meta-analyses

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FDA new drug and and safety reviewers say caution should be exercised in reading too much into an increasing number of meta-analys...

Review Period Set for Ixiaro Vaccine

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Federal Register Notice: FDA determines the regulatory review period for Chiel Jedgang Corp. and Walter Reed Army Institute of Res...

FDA Clears Temperature Monitoring System

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FDA clears a Brain Tunnelgenix Technologies 510(k) for the Abreu BTT 700 System for continuous temperature monitoring.