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Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Adaptive Designs for Medical Device Clinical Studies: 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:2016-07-27。官方主题:Premarket, Good Clinical Practice (GCP), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov