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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...

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.

Merck Adds Birth Defects Precaution to Singulair Label

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Merck adds a new precautions statement about birth defects to its asthma drug Singulair.

Researchers Say Animal Studies Not Useful

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Researchers question the value of some animal studies to human health.

FDA Approves 1st Generic Wellbutrin XL

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FDA rejects a citizen petition and approves the first generic Wellbutrin XL, submitted by Anchen Pharmaceuticals.

FDA Panel Votes Down Hemopure Navy Trial

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FDAs Blood Products Advisory Committee votes against allowing Biopure Corp. to proceed with a U.S. Navy-proposed study with the bl...

FDA Says Genasense Not Approvable

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FDA says Gentas Genasense is not approvable for use with chemotherapy in treating patients with chronic lymphocytic leukemia.