FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals. The change announced Wednesday is the latest move by Trump administration officials vowing to speed up the availability of medical products. Since the 1960s, the FDA has generally required that new drugs be shown safe and effective in two trials. The standard helped ensure that results from the a single study didn't occur by accident or a statistical fluke. But FDA leaders say drug development and research have become far more precise and predictable in recent decades, increasing the reliability of results. The officials predict a boom in drug development as a result of the change.