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Covance Implements iPledge Changes

[ Price : $8.95]

Covance implements FDA-approved revisions to its iPledge risk management program for isotretinoin.

Commission Looking At FDA Sentences

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The federal Sentencing Commission considers changing the sentencing guidelines for FDCA violations at the request of FDA.

FDA Warns Against Vail Bed Use

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FDA says all use of Vail enclosed bed systems should be discontinued if at all possible.

Medtronic Doctor Gifts Being Probed

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Federal prosecutors investigate Medtronics payments and gifts to doctors relating to purchase of its cardiac resynchronication the...

Cipher Disputing Tramadol Letter

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Cipher Pharmaceuticals says it is appealing an FDA approvable letter for its extended-release tramadol through the agencys formal ...

Bush Administration Backs Preemption in Medical Device Suit

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The Bush administration tells the Supreme Court that a federal preemption clause in the 1976 medical device amendments protects de...

FDA Panel Split on Avastin for Breast Cancer

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FDAs Oncology Drugs Advisory Committee votes against recommending approval of Genentechs Avastin used with paclitaxel as first-lin...

CVM Allows Emergency Iron Dextran Imports

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CVM allows the temporary importation of FDA-unapproved injectable iron dextran from Canada to alleviate a U.S. shortage of the dru...

WLF to High Court: Fraud-on-FDA Cases are Preempted

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Washington Legal Foundation tells the U.S. Supreme Court that state fraud on FDA product liability suits are preempted by federal ...

FDA Safety Update on Desmopressin

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FDA orders desmopressin manufacturers to include new safety information in product labeling about severe hyponatremia and seizures...