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FDA Acts Against Unapproved Quinine Drugs

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FDA orders an end to manufacture and distribution of unapproved drugs containing quinine because of safety concerns.

FDA Not Moving to RiskMAPs on Most Drugs: Temple

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CDER associate director for medical policy Robert Temple tells that contrary to public predictions by former chief counsel Dan Tro...

End Viagra DTC, AIDS Group Says

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AIDS Healthcare Foundation breaks its Viagra + Meth = Rx for HIV Infection ad campaign targeting Pfizer DTC ads for Viagra.

Alzheimers Drug Trial to Resume

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FDA says it has lifted a clinical hold on Memory Pharmaceuticals IND for an Alzheimers drug.

NIH Licensing Rare Disease Technologies

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NIH opens a Web site listing technologies related to rare diseases or conditions available for transfer to private interests.

QS Problems at Radiometer, Denmark and U.S.

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FDA warns Radiometer Medical, Bronshoj, Denmark, and Westlake, OH, over Quality System violations.

Merck Plans for 3 NDA Submissions Next Year

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Merck says it expects to submit three NDAs in 2007 for drugs to treat HIV infection, insomnia, and low levels of good cholesterol.

FDA Clears 15-min West Nile Virus Assay

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FDA clears a Spectral Diagnostics Inc. 510(k) for its West Nile Virus IgM Status test that provides results within 15 minutes.

FDA Accepts Vivus NDA for EvaMist

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FDA accepts for review a Vivus Inc. NDA for EvaMist, indicated for treating vasomotor symptoms associated with menopause.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Dupaco, Health Dimensions, Radiometer Medical, Robert Ritch, Skytron, and Spoona...