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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...

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...

FDA Moving on Ethicon Sedasys Appeal

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FDAs Office of the Commissioner says it will hear Ethicons appeal of the CDRH decision that the companys Sedasys PMA is not approv...

Report Notes FDA Slowness in Reviewing Post-marketing Studies

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A new report by Booz Hamilton shows that FDA is slow to review the final study reports required by post-marketing requirements and...

Echo Files 510(k) for Prelude Skin Prep

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Echo Therapeutics files a 510(k) with FDA for the Prelude SkinPrep System and 4% lidocaine cream for transdermal drug delivery.