FDA 发布个体化人类基因组编辑产品 BLA 申报与上市后管理指南草案
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability
FDA 就个体化人类基因组编辑产品的 BLA 申报与上市后管理发布行业指南草案并公开征求意见。该指南针对此类产品的生物制品许可申请资料要求及获批后管理提出考量。
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来源：Federal Register · FDA · federalregister.gov