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Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, 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:2006-04-25。官方主题:Premarket, Good Clinical Practice (GCP)。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov