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FDA Rejects NDA for Neuromed Pain Drug

[ Price : $8.95]

FDA tells Neuromed that it cannot approve its pending NDA for Exalgo (hydromorphone HCl) extended release tablets, indicated for m...

As Agency Digs in, WHO Urged to Break with FDA on Amalgam

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As FDA circles to defend its controversial dental amalgam rule and its shadowy principal author, a dental toxicology group urges t...

FDA Warning on Local Anesthetics Used With Infusion Devices

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FDA orders a new warning on certain local anesthetics about the potential for chondrolysis (necrosis and destruction of cartilage)...

DDMAC Finds Problems in Fosrenol Brochure

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DDMAC says that a Shire Fosrenol brochure omits all risk information, overstates the drugs efficacy, and broadens its indication.

Lumizyme Approval Awaits Plant Fixes

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FDA says that Genzyme must resolve deficiencies at its Allston Landing manufacturing facility before it can receive approval to ma...

Alert on Negative Pressure Wound Therapy

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CDRH alerts healthcare practitioners to reports of death and serious complications associated with use of negative pressure wound ...

CSI Recalls ViperSheath Due to Fractures

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Cardiovascular Systems (CSI) recalls all lots of the ViperSheath Sheath Introducer after receiving reports about sheath stretching...

Dacogen Patient Profile Card Misleading: DDMAC

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DDMAC says that a patient profile card for Eisais Dacogen overstates the drugs efficacy and omits important risk information and m...

Advice Sought on Prevnar 13 Efficacy

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FDA asks its Vaccines and Related Biological Products Advisory Committee to comment on the safety and effectiveness of Pfizers Pre...

FDA Approves 5th H1N1 Vaccine

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FDA says it has approved a 2009 H1N1 influenza virus vaccine produced by ID Biomedical.