利用二代测序技术评估人类基因治疗产品中的基因组编辑安全性4-13-26.pdfVIP

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利用二代测序技术评估人类基因治疗产品中的基因组编辑安全性4-13-26.pdf

SafetyAssessmentofGenomeEditing

inHumanGeneTherapyProducts

UsingNext-GenerationSequencing

DraftGuidanceforIndustry

Thisguidancedocumentisforcommentpurposesonly.

Submitonesetofeitherelectronicorwrittencommentsonthisdraftguidancebythedate

providedintheFederalRegisternoticeannouncingtheavailabilityofthedraftguidance.

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DocketsManagementStaff(HFA-305),FoodandDrugAdministration,5630FishersLane,Rm.

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