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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...

Cell Therapeutics Appeals Pixantrone NDA Rejection

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Cell Therapeutics files a formal appeal with CDER's Office of New Drugs to contest a Complete Response Letter on the companys NDA ...

Republicans Quiz Hamburg on Family Farm Ban for Employees

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Two prominent Republicans challenge a new FDA policy that bans employees from owning family farms.

First Drug to Prevent Lethal Horse Disease OKd

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FDA approves the first drug to prevent potentially lethal fescue toxicosis in horses, Dechra Veterinarys Equidone Gel (domperidone...

FDA Clears Conmed Thermal Tissue Fusion Device

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FDA clears Conmed Corp.s Altrus Thermal Tissue Fusion System for use in surgical procedures.