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FDA Guidance Documents·· 原文未提供具体时分

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff

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FDA 官方历史目录记录;Final guidance;发布日期:2025-12-18。官方主题:Postmarket, Premarket, Real World Data / Real World Evidence (RWD/RWE),。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov