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Robotic Surgery Complications May be Under-reported: Study

[ Price : $8.95]

A Johns Hopkins study says that the number of adverse events associated with robotic surgery may be under-reported.

FDA Transcript Posted on Analgesic Workshop

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FDA posts the transcript from a 5/30-31 workshop on Assessment of Analgesic Treatment of Chronic Pain.

Hospira Recalls 1 Lot of Aminosyn II

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Hospira recalls one lot of Aminosyn II 10%, sulfite-free 500mL, due to foreign particles (human hair) detected in the injection po...

Janssen Files BLA and European Submission for Siltuximab

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Janssen Research & Development submits a BLA and a European marketing application for siltuximab, indicated for treating patients ...

Petition Asks MRI Performance Standards

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Thomas Quinn petitions FDA to amend its regulations to specify performance standards for nuclear MRIs.

Allergan Wants New Guidance on Restasis Bioequivalence

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Allergan asks FDA for a new guidance on determining bioequivalence for a generic form of its Restasis.

CGMP Violations Found at Spains Jabones Pardo

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FDA warns Spains Jabones Pardo about significant CGMP violations in manufacturing OTC drugs.

Stewart Pharma Warned About Compounding, CGMP Violations

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FDA warns Stewart Pharmaceuticals about drug compounding and CGMP violations.

FDA OKs New Vial Size for Hizentra

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FDA approves a CSL Behring supplemental BLA for a 10 g (50 mL) vial size for Hizentra (immune globulin subcutaneous - human).

Military Deployments Delay FDA Studies on LASIK

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U.S. military deployments lead to a prolonged delay in an FDA quality-of-life study in LASIK patients being conducted by the Depar...