美国FDA 指导原则 从使用汇总标本或诊断测试进行传染病检测的捐赠者那里回收的某些人体细胞、组织以及基于细胞和组织的产品(HCTPS)：行业指南 英文原版.pdfVIP

Guidance for Industry Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). Submit written comments on this guidance at anytime to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 10