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Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites BioMarin Pharmaceutical, International Brachytherapy, Mallinckrodt and NeuroScien...

More Counterfeit Test Strips Identified

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FDA releases additional lot numbers and identifying characteristics of counterfeit LifeScan blood glucose test strips.

Novartis Recalling Some Flu Vaccine

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FDA says Novartis is recalling two lots of Chiron flu vaccine received from Cardinal Health Care that were either frozen or shippe...

Harmonization Task Force Documents Out on Device Regs

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Federal Register Notice: FDA announces availability of documents from the Global Harmonization Task Force that may be used by gove...

Draft Guidance Out on Portable Glucose Monitors

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Federal Register Notice: FDA releases a draft guidance on total product life cycle for portable invasive blood glucose monitoring ...

Troy Defends FDA Preemption Position

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Former FDA chief counsel Dan Troy explains the benefits from FDAs defense of its preemption of state failure-to-warn laws.

Drug Recalls Continue Their Sharp Upswing

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CDER acting director of compliance Joseph Famulare reports that a total of 367 drug product recalls have been reported to FDA so f...

FDA Spokeswoman Bro Joins Caremark Rx

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FDAs chief spokeswoman, Susan Bro, resigns to join Caremark Rx as corporate communication senior vice president.

FDA OKs Betaseron for Expanded Use in MS

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FDA approves Berlexs Betaseron for an expanded use in patients with multiple sclerosis who have experienced their first clinical e...

Risk of Guillain Barre Syndrome with Menactra

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FDA says it is still seeing a few cases of Guillain Barre Syndrome being reported in patients receiving Sanofi Pasteurs Menactra v...