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Commissioner Margaret Hamburg: Moving FDA Beyond A Regulatory Agency

Executive Summary

Of the leading candidates for FDA commissioner in the Obama administration, Margaret Hamburg seemed among those with the least relevant experience - an illustrious career to be sure, but one that lacked a decision-making role involving medical products

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Japan Earnings Roundup: Eisai Update On FDA Refusal Letter; Specialty Pharma Santen Packs A Punch In China

The PharmAsia News Japanese earnings roundup is a periodic feature highlighting major developments from Japanese pharma quarterly calls and reports. The prior installment discussed recent developments at Shionogi & Co. Ltd. and Astellas Pharma Inc. ('Japanese Earnings Roundup: Shionogi Rebounds From U.S. Acquisition Woes With C&O Pharmaceutical For China; Astellas Ponders Mirabegron's Reproductive Warning,' PharmAsia News, Aug. 2, 2011).

NIH Rare Diseases Project Could Have Broad Effect On Personalized Medicine

In a high profile effort to speed along personalized medicine, the heads of the National Institutes of Health and FDA are pointing out the possible commercial applications of seemingly small steps, such as the potential for an NIH initiative to accelerate development of therapies for rare diseases to advance personalized medicine in more common illnesses

NIH Rare Diseases Project Could Have Broad Effect On Personalized Medicine

In a high profile effort to speed along personalized medicine, the heads of the National Institutes of Health and FDA are pointing out the possible commercial applications of seemingly small steps, such as the potential for an NIH initiative to accelerate development of therapies for rare diseases to advance personalized medicine in more common illnesses

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