FDA’s prosaic single-trial default standard

FDA leaders’ enthusiasm for making single-trial approvals the default standard is reminiscent of Molière’s Monsieur Jourdain’s excitement over discovering he had been speaking prose all his life.

Writing in the New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad state that their decision to “change the FDA’s default position from two clinical trials to one will substantially reduce costs for sponsors and will speed drugs to market.”...