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.
Food and Drug Administration Regulation and Evaluation of Vaccines
FINANCIAL DISCLOSURE: The author has indicated she has no financial relationships relevant to this article to disclose.
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Valerie Marshall, Norman W. Baylor; Food and Drug Administration Regulation and Evaluation of Vaccines. Pediatrics May 2011; 127 (Supplement_1): S23–S30. 10.1542/peds.2010-1722E
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