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FDA Review Extension on Glaxo/XenoPort NDA

[ Price : $8.95]

FDA extends by three months its review of a GlaxoSmithKline and XenoPort NDA for GSK1838262/XP13512 (gabapentin enacarbil), indica...

Promoting Off-label Uses is Big Business: Bloomberg

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A detailed Bloomberg news report says that many drug companies repeatedly participate in illegal off-label promotion of unapproved...

Guidance on Reducing West Nile Virus Transmissions

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Federal Register Notice: FDA releases a guidance on the use of nucleic acid tests to reduce the risk of transmission of West Vile ...

Five Lots of Tylenol Arthritis Caplets Recalled

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McNeil Consumer Healthcare says it is recalling five specific lots of its Tylenol Arthritis Pain Caplet 100 count bottles with an ...

Boston Scientific Pays $296 Million to End Guidant Probe

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Boston Scientific says it will pay $296 million to resolve a Department of Justice probe into alleged problems with product adviso...

Comments Sought on E-Submissions for Drugs, Biologics

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Federal Register Notice: FDA seeks comments on electronic format labeling requirements for submitting drugs and biologic applicati...

Former FDA Chief of Staff to Lead FDLI

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Former FDA chief of staff Susan Winckler is appointed president of the Food and Drug law Institute.

Comments Sought on Bar Code Requirements

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Federal Register Notice: FDA seeks comments on drug and biologic bar code label requirements.

Guidance on IVD Tests for H1N1

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Federal Register Notice: FDA releases a guidance on emergency use authorization requests for in vitro diagnostic 2009 H1N1 tests.

Caraco Launches Ketorolac Ophthalmic Solution

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Caraco launches a generic form of Allergans Acular ophthalmic solution.