The most important change was the requirement that all new drug applications demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety.
其中最重大的变化是所有新药的上市申请都必须包含对于药物有效性的“实质性证据”，作为对之前申请中安全性论证的一种补充。