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Amid Evasions, FDA Dumps 28 Amalgam Documents on Web

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Amid data gaps and media questions about its level of transparency in setting up a hearing on petitions against its 2009 amalgam s...

CDRH Completes 86% of Strategic Priority Actions

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CDRH says it completed 86% of the strategic priority tasks it wanted to accomplish in FY 2010.

Talecris Biotherapeutics to Begin Trial in Emphysema Patients

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Talecris Biotherapeutics plans a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of Prolastin-C ...

Jury Awards Man $1.1 Million in Levaquin Case

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A federal jury awards a man punitive and compensatory damages from Johnson & Johnson after finding that the company did not proper...

House Backs More Money for FDA

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The Alliance for a Stronger FDA says a House-approved continuing resolution would treat FDA better than many other agencies by giv...

FDA Publishes Advisory Committee Public Comment Guidance

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FDA issues a guidance for people who want to comment during advisory committee sessions.

Teva Plans NDA for Multiple Sclerosis

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Teva Pharmaceutical Industries says it could file an NDA late next year after reporting positive Phase 3 trials involving oral laq...

Review Period Set for Ilaris

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Federal Register Notice: FDA determines the regulatory review period for Novartis Ilaris for the purpose of patent extension.

FDA Sets Bepreve Review Period

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Federal Register Notice: FDA determines the regulatory review period for Ube Industries Bepreve for the purpose of patent extensio...

Sabril Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Lundbeck, Inc.s Sabril for the purpose of patent extensio...