FDA直面消费者的处方药平面广告和推广说明书公开风险信息指南的介绍

Introduction to Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs Guidance for Industry of FDA

FDA于2015年8月公布了"简短摘要和充分的使用说明:在直面消费者的处方药平面广告和推广说明书中公开风险信息"指南草案,主要推荐公开风险信息的"消费者简短摘要"的替代方法,包括对其内容和格式的要求。主要介绍这种替代方法的内容与要求,希望对我国在美国面向消费者的处方药广告的研究方面有帮助并对我国面向医疗专业人员的处方药广告风险信息的规范化要求有所启发。

FDA released “ The Brief Summary and Adequate Directions for Use： Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs Guidance for Industry （draft）”in August, 2015. “The consumer brief summary”--a alternate approach, including requirements for its content and format, is primarily recommended for disclosure of risk information. This paper mainly introduces the alternate approach. It is hoped that the study of consumer-directed advertisements for prescription drugs of the United States is helped and the risk information standardization of the health care provider -directed advertisements for prescription drugs is inspired in our country.