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US ? Dealing with off-label use comments on social media - FDA issues guidance

机译:美国?处理社交媒体上的标签外使用评论-FDA发布指南

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摘要

The US Food and Drug Administration has issued much-awaited guidance on how manufacturers and distributors of prescription drugs and medical devices should respond to unsolicited requests for information on the off-label uses of their products.The guidance also covers requests for information that firms may encounter through emerging electronic media.The guideline is currently in draft form and stakeholders have until 29 March to submit feedback.The document only deals with unsolicited requests (ie initiated by persons or entities that are completely independent of the relevant firm) and contains examples to illustrate that these are different from solicited requests (ie prompted in any way by a manufacturer or its representatives).
机译:美国食品和药物管理局(FDA)已发布了期待已久的关于处方药和医疗设备的制造商和分销商应如何应对未经请求的关于其产品的标签外使用信息的要求的指南,该指南还涵盖了公司可能会要求提供的信息的要求。该指南目前处于草案形式,利益相关者必须在3月29日之前提交反馈。该文档仅处理未经请求的请求(即,由完全独立于相关公司的个人或实体发起),并包含以下示例:说明这些请求与提出的请求不同(即制造商或其代表以任何方式提示)。

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