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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...

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.

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...

FDA OKs Drug for Heavy Menstruation

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FDA approves a Xanodyne Pharmaceuticals NDA for Lysteda tablets (tranexamic acid), a non-hormonal product for treating heavy menst...