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Some drugs and devices receive accelerated approval from the FDA in order to provide potentially important treatments for patients when effective therapies may not be available. These drugs or devices are supposed to have postmarketing studies to definitively show their efficacy or safety, but sometimes this doesn't happen.
Rita F. Redberg, MD, MSc, Aaron S. Kesselheim, MD, JD, MPH, and Robert M. Califf, MD, discuss their articles characterizing studies used for the approval of high-risk medical devices and accelerated approval of drugs by the FDA.
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