FDA's requirement for antihypertensive drug labeling increasing content of lowering blood pressure and improving cardiovascular outcomes
10.7501/j.issn.1674-6376.2017.07.001
- VernacularTitle:FDA对抗高血压药品说明书增加降低血压改善心血管预后内容的要求
- Author:
lai Hui XIAO
1
Author Information
1. 国家食品药品监督管理总局药品审评中心
- Keywords:
FDA;
antihypertensive drug;
labeling;
blood pressure;
outcome;
stroke;
myocardial infarction;
guidance
- From:
Drug Evaluation Research
2017;40(7):885-891
- CountryChina
- Language:Chinese
-
Abstract:
FDA issued Guidance for Industry Hypertension Indication:Drug 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.
