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目的介绍美国FDA人用疫苗监管的相关法规。方法详解FDA相关法规,重点关注其对于安全性和有效性试验的相关要求。结果与结论监管部门和生产厂商共同协作以找到适合的替代试验。
Objective To introduce the relevant laws and regulations governing the use of vaccines by the U.S. FDA. Methods Detailed FDA regulations, focusing on their safety and effectiveness of the relevant test requirements. Results and Conclusions Regulators and manufacturers work together to find suitable alternative tests.