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CDER Rolls Out New Application Review Process

[ Price : $8.95]

CDER Office of New Drugs deputy director Sandra Kweder unveils an improved process for application reviews.

Merck Ends HIV Vaccine Tests

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Merck ends a Phase 2 trial of its V520 investigational HIV vaccine because it was ineffective.

Axcil and Desirin Recalled

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TWC Global recalls Axcil and Desirin dietary supplements because they contain sildenafil and two of its analogs.

FDA Says Company Manipulated Test Results

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FDA investigators are looking into whether Leiner Health Products committed criminal violations at its Fort Mill, SC, manufacturin...

Device Companies Prefer Conservative DTC

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Experts disagree on the role of DTC ads for medical devices and whether companies will try more aggressive DTC spots.

Encysive Proceeding with New Phase 3 Thelin Trial

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Encysive Pharmaceuticals says it will conduct the additional Phase 3 trial of its Thelin that FDA wants to demonstrate the drugs e...

Droperidol Warning Unnecessary Researchers Say

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A new epidemiological study suggests that a 2001 arrhythmia warning on droperidol may be unnecessary.

Fast-Track for Progens Primary Liver Cancer Drug

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FDA grants fast-track status to Progen Pharmaceuticals for its investigational drug for preventing tumor recurrence after curative...

NexMed Files NDA on Alprostadil Cream

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NexMed submits an NDA for its topically applied alprostadil cream, indicated for treating erectile dysfunction.

FDA Accepts The Medicines Co. sNDA for Angiomax

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FDA accepts a supplemental NDA from The Medicines Company for a modified dosing regimen of Angiomax for treating acute coronary sy...