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Updated: Jun 2, 2026

Determination of Vaccine Immunogenicity Using Bovine Monocyte-Derived Dendritic Cells
Published on: May 19, 2023
Food and Drug Administration regulation and evaluation of vaccines
Valerie Marshall1, Norman W Baylor
1Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 405, Rockville, MD 20850, USA.
Abstract:
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.
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