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FDA Awards $1.2 Million for Quality by Design Research

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FDA awards a $1.2 million contract to non-profit National Institute for Pharmaceutical Technology and Education to develop quality...

Will Drug Preemption Decision be Broad or Narrow?

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Drug preemption in the balance: As FDA controversy about it rises in bloggers comments, Supreme Court justices questioning in the ...

FDA OKs 2nd Indication for Treanda

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FDA approves a Cephalon NDA for Treanda for injection, indicated for treating certain patients with indolent B-cell non-Hodgkin's ...

VIBE Field Generator Recalled

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FDA says the recall of VIBE Technologies VIBE field generator is a Class 1 recall.

Bayer Dropping Nimotop Capsules

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Bayer says it is stopping marketing Nimotop due to availability of generic alternatives and reduced demand.

Spectrum Files sNDA for Fusilev

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Spectrum Pharmaceuticals files a supplemental NDA for Fusilev for injection seeking approval for combination use with 5-FU contain...

FDA OKs Roche Cobas HCV Test

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FDA approves Roche Molecular Diagnostics Cobas AmpliPrep/Cobas TaqMan HCV Test.

Scientists Criticize FDA on BPA

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FDAs Science Board says the agency issued a report defending BPA safe use without sufficient scientific evidence.

Savient Files BLA for Gout Therapy

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Savient Pharmaceuticals submits a BLA for pegloticase, indicated for treating patients with treatment-failure gout.

Bradshaw Defends Preemption Principle

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Former FDA chief counsel Sheldon Bradshaw defends the preemption principle he helped steer into FDA regulations.