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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...

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 ...

QS Violations Found in Karl Storz Endovision

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FDAs New England District Office warns Karl Storz Endovision about Quality System violations at its Charlton, MA, production facil...

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...

Acorda Seeks Tighter Bioequivalence for Generic Ampyra

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Acorda Therapeutics petitions FDA seeking rigorous bioequivalence requirements for proposed generic copies of its multiple scleros...

Baxter Recalls 2 Sodium Chloride Injection Lots

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Baxter International recalls two lots of 0.9% sodium chloride injection USP in 100 mL Mini-Bag Plus Container after two complaints...

FDA Clears diaDexus Heart Disease Test

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FDA clears a diaDexus 510(k) for a new screening test that predicts a patients risk of future coronary heart disease events.