美国FDA 指导原则 根据BLA、NDA或ANDA工业和食品药品监督管理局工作人员指南草案提交的紧急使用注射器可靠性论证的技术考虑 英文原版.pdfVIP

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electr