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Medicines approved by FDA on deadline may cause safety risks

Accreditation Connection, March 28, 2008

Medications approved by the Food and Drug Administration on deadline, rather than ahead of deadline, are more likely to cause safety problems, the Washington Post reports.

A Harvard report published in the New England Journal of Medicine looked at decades of drug approvals, and found that medications approved just prior to deadline had a four- to five-fold greater rate of having approval withdrawn or additional safety warnings issued when compared with those that are approved quickly, or miss the appointed deadline.

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