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The regulation of DNA vaccines
1Office of Vaccine Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 20892, Bethesda, MD, US.
Current Opinion in Biotechnology
|June 19, 2001
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.