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Drugs Approved Under Deadline More Likely to Run Into Trouble Later
Date:3/26/2008

e. "For drugs used to treat cardiovascular risk factors, the FDA needs to work with the sponsor, as it wisely did for the approval of torcetrapib, so that large, long-term trials evaluating new drugs that will be used by millions of U.S. individuals start early, evaluate the reduction in cardiovascular disease incidence, and are completed soon after drug approval."

More information

The U.S. Food and Drug Administration has more on PDUFA.



SOURCES: Daniel Carpenter, Ph.D., professor of government, Harvard University, Cambridge, Mass.; Steven Nissen, M.D., chairman, Department of Cardiovascular Medicine, Cleveland Clinic Foundation; March 27, 2008, New England Journal of Medicine; March 26, 2008, Journal of the American Medical Association


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