FDA considers new rules to speed up confirmatory trials of drugs granted accelerated approval

Friday, March 25, 2011 - 17:30 in Health & Medicine

Since 1992, the US Food and Drug Administration has granted accelerated approval to 47 new indications for 35 cancer drugs and in more than half the cases -- 26 indications -- further trials have confirmed the benefits of the drugs. But the agency has concerns about the length of time some drugs have remained on the market without confirmation of their benefits, according to a review article.

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