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FDA Missing PDUFA Review Deadlines

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Analyst Corey Davis says FDA has missed 2008 review deadlines for at least 15 drugs.

Break Up FDA?

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Two securities firm executives recommend breaking up FDA to improve regulatory oversight and restore faith in government.

Fetal Monitoring Public Workshop Slated

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Federal Register Notice: FDA plans a public workshop 11/10 on intrapartum electronic fetal monitoring with computer assisted diagn...

After 5 Deaths, Thoratec Initiates Correction on HeartMate Pumps

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After five patient deaths, Thoratec initiates a medical device correction involving all HeartMate II Left Ventricular Assist Syste...

Bayer Sterile Fill Facility Licensed

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FDA and European regulators license a Bayer sterile filling facility for Kogenate.

FDA Approves Spiration Lung Valve

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FDA approves Spirations IBV lung valve system for controlling some lung air leaks after surgery.

FDA Field Reorganization on Hold Again

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Consulting editor John Scharmann ponders the FDA field changes promised from ORA-21 and the current revitalization effort and con...

J&J Submits Carisbamate Epilepsy NDA

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Johnson & Johnson submits an NDA to FDA for Comfyde, an investigational epilepsy drug.

Watson Sues Over Oxytrol Patent

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Watson sues Barr for patent infringement for its ANDA for generic Oxytrol.

Committee Backs Alzheimers Imaging Studies

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An FDA advisory committee provides guidance for clinical testing of amyloid imaging agents for use in detecting Alzheimers disease...