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FDA, hoping to stave off critics, points to increased drug approvals

By The New York Times  
   November 04, 2011

Federal drug officials on Thursday claimed credit for an increase in the approval of new drugs and argued that the results demonstrated the need for legislation to continue financing the current drug approval system. The Food and Drug Administration approved 35 new drugs in the year that ended in September, a number that was surpassed only once in the past decade. The agency approved 24 of the drugs before they were approved in any other country. And many of them were important advances, including the first new drug for lupus in 50 years, the first new drug for Hodgkin's lymphoma in 30 years, and the first drugs for late-stage melanoma that have been shown to prolong survival. "I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world," Dr. Margaret Hamburg, commissioner of the F.D.A., said at a news conference.

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