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Medical Compression Gains Clearance on DVT Monitoring Device

[ Price : $8.95]

Medical Compression Systems gains 510(k) clearance for its new comprehensive monitoring application, in combination with ActiveCar...

FDA Posts OMB Approvals

[ Price : $8.95]

Federal Register Notice: FDA publishes collections that have been approved by the Office of Management and Budget.

Panels to Discuss Naloxone Products

[ Price : $8.95]

Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees w...

FDA Partial Clinical Hold on Adaptimmune Trial

[ Price : $8.95]

FDA orders a partial clinical hold on an Adaptimmune Therapeutics planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid r...

CGMP Violations at Chinas Concept Products

[ Price : $8.95]

FDA warns Chinas Concept Products Limited about violations of CGMP regulations for finished pharmaceuticals.

Study Questions Company Rep Roles in Surgery

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Researchers raise ethical questions about medical device rep influence with surgeons, including during operations.

Physician Did Not Follow Investigation Plan: FDA

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FDA warns Dr. John Gabriel that he conducted a clinical investigation without following the investigation plan.

FDA OKs Boston Scientific Emblem MRI-friendly Defibrillator

[ Price : $8.95]

FDA approves a Boston Scientific PMA for the Emblem MRI Subcutaneous Implantable Defibrillator System, as well as magnetic resonan...

PhRMA, BIO Principles for Off-Label Communication

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Attorney James Beck says that PhRMA and BIO are telling FDA how the agency should fix its broken off-label promotion regulatory po...

Ninth Circuit Mulls FOIA Summary Judgment Appeals

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Judges on the U.S. Court of Appeals for the Ninth Circuit urge the circuit to re-evaluate how it reviews summary judgments in Free...