title: The regulation of DNA vaccines.
abstract: The framework for regulating DNA vaccines has been in place since the first clinical trial was initiated in the mid-1990s. American and European regulatory guidance has evolved on the basis of insights provided by ongoing preclinical and clinical studies. These include analyses of the safety of DNA vaccines in normal volunteers, and recent data concerning the tissue distribution, persistence, and integration potential of DNA plasmids.
authors.affiliation: Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 20892, Bethesda, MD, US.
authors.forename: H A
authors.initials: HA
authors.lastname: Smith
authors.forename: D M
authors.initials: DM
authors.lastname: Klinman
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004335:Drug and Narcotic Control; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D019444:Vaccines, DNA / Q000235:genetics / Q000592:standards* / Q000627:therapeutic use; D014944:World Health Organization
chemical_list: D019444:Vaccines, DNA