Considerations for Plasmid DNA Vaccines for Infectious Disease Indications

Docket Number:: FDA-2005-D-0211
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

This guidance describes our current recommendations concerning preclinical development and testing of DNA vaccines to prevent infectious diseases. This guidance supercedes the 1996 Points to Consider document. In addition, this guidance finalizes the draft guidance of the same title dated February 2005.

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Considerations for Plasmid DNA Vaccines for Infectious Disease Indications

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