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Harkonen Excluded from Federal Health Programs

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The HHS Inspector General says that former InterMune CEO Scott Harkonen has been excluded from federal healthcare programs for fiv...

FDA 'Close-out' on Teva Warning Letter

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FDA issues a close-out letter to Teva Pharmaceutical Industries indicating that the company has resolved GMP isuues outlined in a ...

Insider Trading Defendant Facing Porn Charge

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Prosecutors charge Andrew Liang, a defendant in an FDA insider trading case, with possessing child pornography.

Many People Dont Understand FDA Drug Approval: Study

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Researchers say simple explanations could help consumers better understand what FDA drug approval does and does not mean about eff...

Cinryze Phase 2 Study Starts

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ViroPharma and Halozyme say they are starting a Phase 2 Cinryze trial using Halozymes Enhanze subcutaneous drug administration tec...

Upmost or Utmost? FDA Seems Not to Know

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FDA Webview editor Jim Dickinson takes three top FDAers to task for not seeming to know the importance of spelling.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Quality Manufacturing, John Caton, Jr., M.D., For Earth, Lonza Biologic...

Genentech NDA for Skin Cancer Drug

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Genentech files an NDA for vismodegib, indicated for treating people with advanced basal cell carcinoma when surgery is not an opt...

FDA 'Complete Response' on Simponi sBLA

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FDA issues Janssen Biotech a complete response letter on a supplemental BLA for Simponi (golimumab) seeking an expanded label for ...

Info on Tobacco Substantial Equivalence OKd by OMB

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Federal Register Notice: The Office of Management and Budget approves a collection of information on exemption from substantial eq...