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Beware FDA User Fees Pandoras Box by Democrats

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Washington commentator Robert Steeves reviews user fee politics and predicts a Pandoras Box on Capitol Hill after the Democrats ta...

Vitriolic Partisan Clashes Coming, Miller Warns

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Former FDAer Henry Miller sees hard times ahead for FDA and other regulatory agencies when Democrats take control of Congress.

CDRH Panel Backs PMA on GeneSearch Assay

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CDRHs Immunology Devices Panel votes 9 to 1 in favor of approval with conditions for a Veridex PMA for its GeneSearch BLN assay, a...

High ESA Dose Linked to Cardiovascular Problems

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FDA issues a safety alert for potentially increased risk for cardiovascular problems in patients taking higher-than-recommended do...

Herceptin Indication Expanded

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FDA approves an expanded indication for Genentechs Herceptin for use with other cancer drugs in treating HER2 positive breast canc...

First ANDAs for Generic Risperdal, Cardene

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FDA reports it has received ANDAs with for generic copies of Janssen Pharmas Risperdal 3 mg and 4 mg orally disintegrating tablets...

Guidance on CTDI Alternate Measure

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FDA says it will exercise enforcement discretion in allowing CT manufacturers to use an alternate measure of the computed tomograp...

Frustrated, Grassley Places Hold on von E Nomination

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Senate Finance Committee chairman Chuck Grassley (R-IA) places a hold on FDA acting commissioner Andrew von Eschenbachs nomination...

Panel to Discuss Lipoprotein Assays

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Federal Register Notice: FDAs Clinical Chemistry and Clinical Toxicology Devices Panel will meet 12/6 to discuss the FDA Critical ...