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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...

FDA Hires CRO for Adverse Event Surveillance Review

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FDA hires PPD, Inc. to evaluate CDERs post-approval spontaneous adverse event surveillance system.

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 ...

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...

Panel to Discuss sNDA for Crestor

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/15 to discuss Astra Zenecas sNDA ...

FDA Corrects FY 2010 PDUFA Fees

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Federal Register Notice: FDA corrects the errors in an 8/3 notice announcing the FY 2010 PDUFA fees.

Public Workshop on Arboviruses

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Federal Register Notice: FDA plans a public workshop 12/14-15: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue, and ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites 17 LASIK facilities.

FDA Clears Faster AdvanDx FISH Test

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FDA clears an AdvanDx 510(k) for a 90-minute protocol for its E. faecalis/other enterococi PNA FISH test.