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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...

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...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Repromed Fertility Center, Karl Storz GmbH, and Voss Plastics.

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...

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 ...

2 Innovations Can Change Drug Production: Consultants

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Consultants Marcus Ehrhardt and Peter Behner say two drug production innovations will significantly change the currently stagnant ...