FDA于2015年8月公布了"簡(jiǎn)短摘要和充分的使用說明:在直面消費(fèi)者的處方藥平面廣告和推廣說明書中公開風(fēng)險(xiǎn)信息"指南草案,主要推薦公開風(fēng)險(xiǎn)信息的"消費(fèi)者簡(jiǎn)短摘要"的替代方法,包括對(duì)其內(nèi)容和格式的要求。主要介紹這種替代方法的內(nèi)容與要求,希望對(duì)我國(guó)在美國(guó)面向消費(fèi)者的處方藥廣告的研究方面有幫助并對(duì)我國(guó)面向醫(yī)療專業(yè)人員的處方藥廣告風(fēng)險(xiǎn)信息的規(guī)范化要求有所啟發(fā)。

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.