The US Food and Drug Administration (FDA) may be issuing shaky last-minute drug approvals, according to a new study.
In an article in the New England Journal of Medicine (D. Carpenter et al. N. Engl. J. Med. 358, 13541361; 2008 ), Daniel Carpenter and his colleagues at Harvard University studied 313 drugs approved for market between 1993 when drug companies began paying for reviews, and penalties came in for the agency missing deadlines and 2004.
They found that 14% of drugs approved in the two months before deadlines had serious safety problems requiring 'black box' label warnings, market withdrawals, or both, compared with 3.2% approved earlier in the process. The FDA is disputing Carpenter's figures.










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Two international trials of Merck & Co. Inc.’s experimental AIDS vaccine were stopped after researchers realized the vaccine did not prevent infection with the AIDS virus.






