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Advisors Recommend Alair System Approval

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Members of FDAs Respiratory Therapy Devices Panel vote 6-1 to recommend approval with conditions of Asthmatx Alair System bronchia...

Genasense Trial Doesnt Meet Endpoints

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Genta says the AGENDA Phase 3 trial of Genasense failed to meet a co-primary endpoint and secondary endpoints.

Novartis H1N1 Vaccine Production Accelerating

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Novartis says it has almost tripled H1N1 vaccine yield after moving to a newer seed virus and production has been accelerating as ...

TMJ Implants Case Shows the Power of Regulations

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FDA Webview editor Jim Dickinson reviews FDAs crushing defeat of TMJ Implants Inc. in the Tenth Circuit Court of Appeals and sees ...

AstraZeneca Pulls Lung Cancer NDA

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AstraZeneca withdraws its NDA Zactima (vandetanib) 100mg in combination with chemotherapy that sought approval for use in patients...

Qualitest Recalls Accusure Syringes

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Qualitest Pharmaceuticals recalls all Accusure Insulin Syringes that have been distributed nationwide between 2002 and 2009.

Panel Recommends More ABthrax Tests

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Members of FDAs Anti-infective Drugs Advisory Committee say it is likely that Human Genome Sciences ABthrax may help treat people ...

Latest FDA Inspection Documents from FOI Posted

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FDA Webview posts to our site the latest FDA inspection documents we have received pursuant to our FOIA requests, for: Abbott Labo...

Is the H1N1 Pandemic Becoming a Vaccine Debacle?

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FDA Webview Washington editor David McFarland says its likely that current problems in producing and distributing H1N1 vaccines wi...

FDA Clears Fibroid Removal System

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FDA clears an Interlace Medical 510(k) for the MyoSure Hysteroscopic Tissue Removal System, intended for use in removing submucosa...