美国食品药品监督管理局（FDA）周二发布指南，旨在明确制药公司如何开发、分发和标注与其处方药配套使用的应用程序。以下是部分细节：该政策概述了此类应用程序中的内容何时必须提交给美国食品药品监督管理局、这些应用程序何时应在药品处方信息中被提及，以及公司需要向这家卫生监管机构提供哪些信息。
The US FDA on Tuesday issued guidance aimed at clarifying how drug companies can develop, distribute and label apps used alongside their prescription medicines. Here are some details: The policy outlines when content in such apps must be submitted to the US Food and Drug Administration, when those apps should be referenced in a drug's prescribing information, and what information companies need to provide to the health regulator.
FDA表示，与医疗器械相关联的应用程序，例如与哮喘吸入器配套的软件，通常应纳入相关药品的标签中。FDA称，用于追踪症状、提供提醒或提供指导的独立应用程序，只有在这些应用程序对药品的安全有效使用必不可少或能带来有意义的临床获益时，才应列入标签。在大多数情况下，通过配套应用程序向患者展示的信息将被视为宣传材料，这与该监管机构对其他形式药品广告的处理方式一致。FDA表示，该指南旨在减少制药商和技术开发者的监管不确定性，同时维持安全性和有效性标准。
Apps linked to medical devices, such as software paired with an asthma inhaler, should generally be included in an associated drug's label, the FDA said Standalone apps that track symptoms, provide reminders or offer coaching should be listed in the label only if these apps are essential for the medicine's safe and effective use or offer meaningful clinical benefit, it said In most cases, information displayed to patients through a companion app will be treated as promotional material, in line with the regulator's approach to other forms of drug advertising The FDA said the guidance intends to reduce regulatory uncertainty for drugmakers and technology developers while maintaining safety and effectiveness standards