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Hamburg Touts FDA Steps on Compounded Drugs

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FDA commissioner Margaret Hamburg says the agency is moving forward on several fronts to prevent a repeat of contaminated compound...

Pozen Gets 2nd Complete Response Letter on Yosprala

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FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, ...

FDA Clears Sorins Memo 3D ReChord Annuloplasty Ring

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FDA clears Sorin Groups Memo 3D ReChord annuloplasty ring for mitral valve repair.

FDA Grants Priority Status for Gastrointestinal Sealant

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FDA grants priority review for Cohera Medicals Sylys Surgical Sealant to help reduce anastomotic leakage in gastrointestinal proce...

FDA Approves Cerus Plasma Pathogen Reduction Device

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FDA approves a Cerus Corp. BLA for its Intercept Blood System for plasma, a pathogen reduction system for reducing the risk of tra...

Appeals Court Affirms Bayer Whistleblower Award

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A federal appeals court affirms most of an Arkansas federal jury award to a Bayer Corp. sales representative who was allegedly fir...

Electronic Format Guidances Out

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FDA issues its first two guidances implementing new legal provisions relating to regulatory submissions in electronic format.

FDA Clears ReFlows SpeX Shapeable Support Catheter

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FDA clears a ReFlow 510(k) for its SpeX Shapeable Support Catheter for use in the peripheral vasculature.

2 Charged with Murder in NECC Compounding Rx Deaths

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The federal government charges New England Compounding Center (NECC) and head pharmacist Barry J. Cadden and supervisory pharmacis...

David Kessler Wrong on 510(k) Laws Intent, Lawyer Says

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Medical device lawyer Larry R. Pilot corrects a Wall Street Journal statement by former FDA commissioner David Kessler that the in...