The US Food and Drug Administration (FDA) has changed its long-standing rules and will now require only one clinical trial instead of two by default when approving new drugs and health products.[1][3] This change was announced by FDA Commissioner Dr. Marty Makary and his representative Dr. Vinay Prasad in an article published in the New England Journal of Medicine.[1][3] The two-trial requirement dates back to 1960, when Congress passed a law requiring the FDA to review data from "adequate and well-controlled studies" before approving new drugs.[3] The second test was to confirm that the results of the first test were not a coincidence and can be repeated.[1][3] However, since the 1990s, the FDA has gradually begun to accept individual trials when approving treatments for rare or fatal diseases where companies have difficulty testing large numbers of patients.[3][4] In the last five years, approximately 60% of the first drugs were approved annually based on a single trial.[1][3][4] FDA management anticipates that this change will trigger a "wave of drug development".[1][3] According to the former director of the FDA's drug division, Dr. Janet Woodcrock's new policy will primarily affect drugs for common diseases that have not previously met the criteria for a reduced testing requirement.[1][3]