Basic principles and examples on which FDA to determine whether firms' medical product communications are consistent with FDA-required labeling
10.7501/j.issn.1674-6376.2017.09.009
- VernacularTitle:FDA判断公司医疗产品的交流信息是否符合药品说明书的基本原则与实例
- 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;
medical product;
communication;
guidance;
use of product;
labeling
- From:
Drug Evaluation Research
2017;40(9):1241-1247
- CountryChina
- Language:Chinese
-
Abstract:
FDA issued Medical Product Communications That Are Consistent With FDA-Required Labeling-Questions and Answers Guidance for Industry in January 2017,which introduced basic principles on which FDA to determine whether firms'medical product communications about the use of the product are consistent with the FDA-required labeling (i.e.whether in the allowable range of labeling) and listed examples.This paper introduces the guidance,and is expected to be beneficial to the standardization and supervision of the medical product communications in China.
