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FDA moves slowly on required postapproval drug studies; other agency procedures scrutinized
More than 3 years passed before the efficacy of most drugs given accelerated approval by the FDA from 2009 to 2013 was validated, according to findings published in JAMA. A second study, also in JAMA, suggests that more than half of the changes made to high-risk medical devices that were approved by the FDA occurred after trials that were not masked, controlled or randomized.