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Amgen Sues Hospira Over Epogen Biosimilar Submission

[ Price : $8.95]

Amgen files suit against Hospira over its alleged failure to disclose to Amgen its manufacturing information under the Biologics P...

Judge Dismisses Treanda Failure-to-Warn Case

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A New York federal judge says labeling for Cephalons Treanda adequately warned of potential adverse effects cited in a failure-to-...

FDA Clears Advanced Catheter Therapies Delivery Catheter

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FDA clears an Advanced Catheter Therapies (ACT) 510(k) for the Occlusion Perfusion Catheter that allows additional sizes for the u...

Science Board Group Sees FDA Science Progress

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A Science Board subcommittee acknowledges FDA science improvements since a critical 2007 report and urges additional steps in the ...

FDA Warning on Dosing Errors with Avycaz

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FDA issues a warning on the risk for dosing errors with Forest Pharmaceuticals intravenous antibacterial drug Avycaz (ceftazidime ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Chaotic Labz, CMP Industries, NSC Pearson, and Sironis.

Info on Samples and Protocols Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on request for samples and protocols to the Office of Ma...

FDA Classifies Vision Aid into Class 2

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Federal Register Final order: FDA classifies the oral electronic vision aid into Class 2.

Safety Audit of FDA Labs Finds Areas for Improvement

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An HHS workgroup formed after smallpox vials were discovered in an FDA laboratory in 2014 completes an audit of the agencys labora...

DoJ Targeting Corporate Execs

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The Department of Justice says it is ramping up efforts to target corporate executives who break the law, rather than just their c...