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Maisel Lists CDRH Strategic Priorities

[ Price : $8.95]

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 ...

Point-of-Care Communication Channel Growing: Consultants

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A ZS Associates study says point-of-care communications is growing much faster than overall direct-to-consumer communications.

FDA Approves Novartiss Signifor for Treating Acromegaly

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FDA approves a Novartis NDA for Signifor (pasireotide) long-acting release for treating patients with acromegaly who have had an i...

Acura Pharma Petitions FDA on Purdue Pain Drug NDA

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Acura Pharmaceuticals petitions FDA asking it to rescind acceptance of a Purdue Pharma 505(b)(2) NDA that Acura believes was recen...

Genentech NDA Filed for Melanoma Therapy

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Genentech files an NDA for cobimetinib for treating, in combination with Zelboraf (vemurafenib), patients with BRAF V600 mutation-...

EOS Imaging Hip Arthroplasty Planning Software Approved

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FDA approves an EOS imaging PMA for its hipEOS, a 3D hip arthroplasty planning software based on EOS stereo-radiographic 2D/3D ima...