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No Evidence Found that Company Info Improves Prescribing

[ Price : $8.95]

Researchers say studies have not proven a positive impact of drug company information on prescribing quality.

First Amendment Defense May Not Help Device Co. Execs

[ Price : $8.95]

A bnet online column says that medical device company executives may find that a free speech defense in off-label marketing cases ...

FDA Clears Neurowave Nausea Device

[ Price : $8.95]

FDA clears a Neurowave Medical Technologies 510(k) for Reletex, a transdermal neuromodulation device for alleviating nausea when u...

FDA Approves Herceptin for Stomach Cancer

[ Price : $8.95]

FDA approves Genentech's Herceptin (trastuzumab) in combination with chemotherapy for treating HER2-positive metastatic cancer of...

Unique Device Identifiers Coming on Strong: CDRH

[ Price : $8.95]

CDRH senior advisor Jay Crowley cautions that Unique Device Identifiers are certain to be a major regulatory concern in the future...

CDRH: Integrate Risk Management Throughout All QS

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CDRH says medical device manufacturers should integrate risk management concepts throughout all aspects of their quality systems, ...

FDA Clears PinPointe FootLaser for Nail Fungus

[ Price : $8.95]

FDA clears PintPointe USAs PinPointe FootLaser for treating nail fungus.

Hamburg Vows Full Consideration of Industrys 510(k) Views

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FDA commissioner Margaret Hamburg seeks to reassure medical device manufacturers on impending changes to the 510(k) process, promi...

New Warning for Some Prostate Cancer Drugs

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FDA asks gonadotropin-releasing hormone agonist manufacturers to add labeling on an increased risk of diabetes, heart attack, stro...

FDA Clears Burton Medical Surgical Light

[ Price : $8.95]

FDA clears a Burton Medical for the AIM-200 O.R. light for surgical lighting applications in operating rooms.