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Appeals Court Affirms Bayer Whistleblower Award

[ Price : $8.95]

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

[ Price : $8.95]

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...

FDA Proposes Rule on E-prescribing Information

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FDA issues a proposed rule to require electronic distribution of the prescribing information intended for health care professional...

Maisel Lists CDRH Strategic Priorities

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CDRH deputy director for science William Maisel says the Center is working to ensure that U.S. patients are the first in the world...

Patient Voices Introduce Bias: Commentator

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Drug industry commentator David Grainger says listening to patient advocacy groups can bring a bias into healthcare decision-makin...

FDA Clears Bovie Medical Surgical Generator

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FDA clears a Bovie Medical 510(k) for its Bovie Ultimate generator, a high-frequency electrosurgical generator that can be used fo...

Voss Plastics Warned About QS Violations

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FDAs Dallas District Office warns Voss Plastics about Quality System and Medical Device Reporting violations in its manufacturing ...

DoJ Nixes Prosecution of Pair Who Used Unapproved Drugs in Practice

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The U.S. Justice Department drops a case against physician Anindya Kumar Sen and his wife and practice manager Patricia Posey Sen ...