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FDA Panel Backs Wider Use of Gastric Band

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FDA's Gastroenterology and Urology Devices Panel votes to recommend wider use for Allergan's LAP-Band System for weight reduction ...

FDA Press Officers Stole Our Freedom: Dickinson

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In a new Columbia Journalism Review article, FDA Webview editor Jim Dickinson tells how government press officers stole our freedo...

DDMAC Again Cites an Allergan Lumigan Promo

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DDMAC says Allergan should stop using a Lumigan mailer directed at healthcare professionals because it allegedly contains unsubsta...

Seattle Genetics BLA Planned for Lymphoma Therapy

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Seattle Genetics says it plans a first quarter 2011 BLA for brentuximab vedotin (SGN-35) for treating relapsed or refractory Hodgk...

Comments Sought on Exports Not Approved in U.S.

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Federal Register Notice: FDA seeks comments on requirements for persons exporting products that may not be marketed in the U.S.

Guidance on Transmission of T. cruzi

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Federal Register Notice: FDA sends to the Office of Management and Budget and releases a guidance: Use of Serological Tests to Red...

Review Period Set for B & Ls Besivance

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Federal Register Notice: FDA determines the regulatory review period for Bausch & Lombs Besivance for the purpose of patent extens...

Stelara Review Period Set

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Federal Register Notice: FDA determines the regulatory review period for Centocor Ortho Biotechs Stelara for the purpose of patent...

Panel to Discuss Bristol-Myers BLA to Treat Melanoma

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 2/9 to discuss Bristol-Myers Squibbs BLA for Yervoy for...

Panel to Discuss Bayer NDA for Diagnostic Imaging

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Federal Register Notice: FDAs Peripheral and Central Nervous Systems Drugs Advisory Committee will meet 1/20/11 to discuss Bayer H...