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Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of 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:2016-06-21。官方主题:Premarket, Good Clinical Practice (GCP), Pediatric Product Development, Premarket Approval (PMA), HUD/HDE。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov