FDA处方药说明书要求三则

FDA's three requirements on labeling for prescription drug

本文简要介绍FDA对处方药说明书要点和目录的要求以及对抗高血压药适应症有关心血管最终疗效描述的要求,并列举实例。希望对我国说明书的管理和撰写有所启迪。

The article briefly introduces FDA＇s requirements on highlights and contents of labeling for prescription drug as well as cardiovascular outcome claims for drugs that are indicated to treat hypertension.And that the instances are cited.It is expected to enlighten us on managing and writing of labeling.