FDA's requirement for antihypertensive drug labeling increasing content of lowering blood pressure and improving cardiovascular outcomes / 药物评价研究

ABSTRACT

FDA issued Guidance for Industry Hypertension IndicationDrug Labeling for Cardiovascular Outcome Claims in March 2017,requires that antihypertensive drug labeling should increase the content that lowering blood pressure can prevent serious cardiovascular events,provide a standard description of the INDICATIONS AND USAGE and CLINICAL STUDIES section in labeling in detail.The aim is to encourage the rational use of antihypertensive drugs in hypertensive patients,to reduce blood pressure to the target level,and to improve the outcomes.This paper introduces the main contents of guidance and enumerates a example,and look forward to that antihypertensive drug manufacturers and drug regulatory authorities can learn from this practice of FDA,and work together to revise antihypertensive drug labeling as soon as possible in our country,so as to benefit patients.