The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.
Going forward, the FDA's “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday.
