Food and Drug Administration regulation and evaluation of vaccines.

Marshall V; Baylor NW

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Food and Drug Administration regulation and evaluation of vaccines.

机译：食品药品监督管理局对疫苗的监管和评估。

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The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.

机译：美国的疫苗批准程序受美国食品和药物管理局生物评估与研究中心的监管。从临床前研究到许可后的整个生命周期，疫苗都经过严格的测试和监督。制造商必须遵守良好的生产规范和控制程序，以确保疫苗的质量。根据《法规规则》第21章的要求，许可疫苗必须符合严格的安全性，功效和效力标准。

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《Pediatrics: Official Publication of the American Academy of Pediatrics》 |2011年第1期|共8页
作者
Marshall V; Baylor NW;
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正文语种 eng
中图分类儿科学;
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1. Food and Drug Administration regulation and evaluation of vaccines. [J] . Marshall V, Baylor NW Pediatrics: Official Publication of the American Academy of Pediatrics . 2011,第Suppla1期

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6. Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research [O] . Marc Kusinitz, Emily Braunstein, Carolyn A. Wilson 2017

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Food and Drug Administration regulation and evaluation of vaccines.

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