title: Food and Drug Administration regulation and evaluation of vaccines.
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.
authors.affiliation: Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 405, Rockville, MD 20850, USA.
authors.forename: Valerie
authors.initials: V
authors.lastname: Marshall
authors.forename: Norman W
authors.initials: NW
authors.lastname: Baylor
mesh_terms: D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D008004:Licensure / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D014612:Vaccines