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CBER Issues FY 2009 Report

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CDER issues its annual report for FY 2009 highlighting its work on the pandemic flu.

Utah False Claims Suit Against Avandia 'Wonder' Drug

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Utah files a state false claims suit against GlaxoSmithKline for allegedly marketing Avandia as a new wonder drug to treat Type 2 ...

Outsourcing FDA Training is a Good Idea; Now Transparency?

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Editor Jim Dickinson critiques a Wall Street Journal critique of outsourced FDA management training contracts and suggests the con...

FDA Reviewers Question Lupus Drug's Risk/Benefit

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An FDA review summary of Human Genome Sciences' BLA for lupus therapy Benlysta (belimumab) shows that the serious risks were great...

Centocor Seeks Broader Simponi Indication

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Centocor submits a second 2010 sBLA to FDA seeking to broaden the indication for its Simponi.

J&J Says Risperdal Settlement Discussions Underway with Feds

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Johnson & Johnson says it is trying to resolve potential federal civil and criminal charges relating to Risperdal marketing.

Comparative Effectiveness Studies Need Research Network: Woodcock

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CDER director Janet Woodcock makes the case for a new federal research infrastructure to involve community doctors in comparative ...

NephRx Begins Kidney Transplant Drug Trial

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NephRx begins a Phase 1 clinical trial of its lead compound NX001, a kidney growth factor peptide under development for preventing...

FDA Denies Request to Limit Levothyroxine Indication

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FDA denies a petition asking for changes in labeling for levothyroxine products.

UCB Asks FDA to Block Xyzal Carve-outs

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UCB asks FDA to reject ANDAs from any generic drug manufacturer citing Xyzal as the reference-listed drug but carving out labeling...