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FDA OKs Generic Ellence

[ Price : $8.95]

FDA approves an Abraxis Pharmaceutical Products ANDA for a generic copy of Pfizers Ellence.

SenoRx System with Ultrasound Cleared

[ Price : $8.95]

FDA clears a SenoRx 510(k) for the SenoSonix System, an integrated version of the firms EnCor breast biopsy system and an ultrasou...

FDA Litigators Shift Focus from Personal Accountability

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Consulting editor John Scharmann questions an apparent FDA trend away from applying the Park doctrines strict personal accountabil...

FDA Changing Vaccine Processing Regs

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FDA publishes a direct final rule loosening requirements for processing live vaccines.

FDA Approves Merck Januvia sNDA

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FDA approves a Merck supplemental NDA for expanded labeling on diabetes drug Januvia.

FDA Clears Aperio Technologies HER2 Device

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FDA clears Aperio Technologies HER 2 image analysis application to aid in detecting and quantifying HER2 protein expression.

Advisors Back Phosphate Binder Use

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Members of FDAs Cardiovascular and Renal Drugs Advisory Committee vote 8-4 to recommend using phosphate binders to treat hyperphos...

$4 Million to C-Path for Drug Interactions Research

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HHS awards $4 million to the Critical Path Institute to expand its programs on preventing dangerous drug interactions.

FDA Backs CMS on Use of ESAs

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FDA says Medicares national coverage determination allowing dosing of erythropoiesis-stimulating agents in cancer patients up to 1...

Quality System Problems at EM Probe

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FDAs Seattle District Office warns EM Probe over QS problems in its manufacture of the EM-pulse Trilogy and EM-pulse Solo.