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Dual-filing feat a rarity for little guy

Wednesday, February 17th, 2010

You may have read recently about a small biotech outfit in New Jersey having successfully submitted simultaneous regulatory filings in the United States and Europe for Luveniq, a new oral treatment for non-infectious uveitis, an inflammatory condition of the eye that can lead to blindness (see the release here). You ...

Posted in Uncategorized, clinical trials, filed for approval | No Comments »

More muscle needed for regulatory science …

Thursday, September 17th, 2009

Or all the billions of dollars poured into biomedical research and development in the U.S. won’t mean a thing. That was the prevailing message delivered yesterday by new FDA commissioner Margaret Hamburg during a candid keynote address at the Regulator Affairs Professionals Society’s annual conference in Philadelphia. “In order to strengthen ...

Posted in Uncategorized | No Comments »

Regulatory minds meet in Philly

Tuesday, September 15th, 2009

  The City of Brotherly Love is the site of this week's Regulatory Affairs Professionals Society's 2009 Annual Conference & Exhibition. With much change afoot these days at FDA and healthcare reform dominating the American consciousness (more on that later), it's no surprise the theme for this year's event is "Succeed in ...

Posted in Uncategorized, animals, cancer, clinical trials, vaccines | No Comments »

   
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