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

Since 1992, the U.S. 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 published online March 25 in the Journal of the National Cancer Institute. New requirements and fines are possible solutions say the authors, from FDA's Office of Oncology Drug Products.

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