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GENpoll: Jan 09, 2012

FDA in 2011

KEYWORDS:
FDA
,
Regulatory

Grade FDA’s performance on new drug approvals in 2011.

22.2%

37.8%

15.6%

8.9%

15.6%

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During 2011, FDA approved 35 new medicines. This was, according to the agency, among the highest number of approvals in the past decade, surpassed only by 37 approvals in 2009. Of the 35 drugs given the go-ahead, two were approved with a molecular test, making them the first companion drug-diagnostic sanctions. Such tests will be key drivers of drug development in the future. Seven newly sanctioned medications provided advances in cancer treatment, and 10 were for orphan diseases. Notably, the first new therapy for lupus in 50 years was green-lighted this past year. Three cancer drugs were given the go-ahead in less than six months. Two-thirds of all the drugs sanctioned last year were completed in a single review cycle, and 34 were approved on or before the agreed-upon review time targets. How do you think the FDA fared?

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