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Neurochem Responds to FDA on Kiacta

[ Price : $8.95]

Neurochem responds to an FDA approvable letter for its Kiacta, for the proposed indication of Amyloid amyloidosis.

Crawford to Plead Guilty Over Unreported Stocks

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Former commissioner Lester Crawford is charged with two criminal misdemeanors related to stock holdings and conflicts of interest,...

Warwick Moving Away from CFC Inhalers

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FDA says Schering-Ploughs Warwick Pharmaceutical will begin 11/1 to shift from CFC-based albuterol inhalers to HFA-based inhalers ...

Industry Sneaks Regulatory Issues in Critical Path Meetings

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CDER Office of Translational Sciences director Shirley Murphy says some companies have been blindsiding reviewers with unrelated r...

Counterfeit One Touch Test Strips Reported

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FDA issues a nationwide alert for counterfeit blood glucose test strips to be used in LifeScan One Touch monitors.

FDA, Duke Sign MOU on Cardiovascular Safety

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Federal Register Notice: FDA and Duke University sign a memorandum of understanding to develop plans toward identifying cardiovasc...

Global Drug Review Cooperation Must be SOP: FDA

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FDA associate commissioner for international and special programs Murray Lumpkin says Regulatory cooperation (among health authori...

SSRI Use Can Lead to Serotonin Syndrome

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FDAs September MedWatch says four SSRIs can lead to potentially fatal serotonin syndrome.

Economists Say FDA Balances Speed and Safety

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A National Bureau of Economic Research report says FDA does a reasonable job of balancing fast drug approvals and ensuring drug sa...

CDER Officials Say OOS Guidance Most Important

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CDER officials highlight significant revised topics from the Centers newly released out-of-specification test results guidance.