Researchers examined the 20 therapeutic drugs the FDA approved in 2008, eight of which “were deemed sufficiently innovative to receive expedited review.”
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Expedited drugs took a median of 5.1 years from development to market, 2.4 years less than the median for drugs under the standard process. During that time, standard drugs were tested on a median of 580 patients, while expedited drugs were tested on a median of just 104 patients.
In addition, among all drugs approved in 2008, the FDA issued 5 boxed warnings. By 2013, 5 drugs received new or expanded boxed warnings. Of the 85 postmarket studies the FDA ordered, only 31 percent had been completed by 2013 and only 9 percent had been sent to the FDA for review.
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