Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market
By Zachary Brennan -
Published 15 August 2017
Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.
Categories: News, US, FDA, Drugs, Ethics, Medical Devices, Regulatory intelligence, Regulatory strategy
Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf