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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...

FDA OKs Belcher Pharma ANADA

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Federal Register Final rule: FDA approves Belcher Pharmaceuticals ANADA for veterinary use of carprofen caplets in dogs.

FDA OKs Elanco Animal sNADA

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Federal Register Final rule: FDA approves an Elanco Animal Health supplemental NADA to revise monensin concentration of cattle fee...

FDA Approves Elanco sNADA for Cattle, Goat Feed

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Federal Register Final rule: FDA approves Elanco Animal Healths sNADA to remove a 30-day expiration labeling for monensin goat and...