1/22/2014

Research reported in the Journal of the American Medical Association found that more than one-third of FDA new drug approvals released in the U.S. between 2005 and 2012 were based on one large clinical study, while 91 indications were only based on studies using surrogate endpoints as a primary outcome. A second JAMA study noted that although devices are subject to an average of 50 changes after initial approval, the upgrades undergo limited scrutiny and may not need to be evaluated in human clinical trials. "If you took a device approved 15 years ago and you put it side by side with the one from today, they might look nothing like each other," said researcher Aaron Kesselheim.

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