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Medtronic Neuromodulation Warned About Quality System Violations

[ Price : $8.95]

FDAs Minneapolis District Office warns Medtronic Neuromodulation about Quality System problems at its manufacturing facility.

FDA Says Reumofan Products Have Potentially Harmful Ingredients

[ Price : $8.95]

FDA again warns consumers that Riger Naturals Reumofan Plus and Reumofan Plus Premium contain prescription drug ingredients not li...

FDA Top Cop Corrigan to Head Europe Office

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FDA announces that associate commissioner for regulatory affairs Dara Corrigan is appointed director of FDAs Europe Office, to be ...

Ocular Therapeutix Plans Phase 2 Glaucoma Study

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Ocular Therapeutix plans a pilot Phase 2 study to evaluate its travoprost punctum plugs for treating ocular hypertension and glauc...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Augustine Biomedical & Design, Horiba Instruments, Inc., dba Horiba Medical, Inn...

FDA Extends Review of Pfizer NDA for Arthritis Drug

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FDA extends by three months its review of a Pfizer NDA for tofacitinib after recently requesting a new analysis of existing data.

Cord Blood Stem Cell Autism Trial Opening

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FDA says Sutter Neuroscience Institute and Cord Blood Registry may proceed with a clinical study of using childrens own cord blood...

FDA Clears Covalon Tech SurgiClear Dressing

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FDA clears a Covalon Technologies 510(k) for its SurgiClear antimicrobial silicone adhesive film dressing.

Gattex NDA Sent to Advisory Committee

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FDA says the Gastrointestinal Drugs Advisory Committee will discuss the NPS Pharmaceuticals Gattex NDA for treating adults with sh...

Workshop on Post-Approval Studies

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Federal Register Notice: FDA plans a public workshop 8/30, Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in E...