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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。
In August 2015, the FDA published “a brief summary and full instructions for use: disclosing the risk information in a direct-to-consumer prescription drug print and promotion manual,” the draft guideline, a “short summary of consumers that primarily recommend disclosing risk information” ", Including its content and formatting requirements. It mainly introduces the contents and requirements of this alternative method and hopes to help our research on consumer drug prescription drugs in the United States and to inspire the standardization of prescription drug advertisement risk information for medical professionals in China.