Issue Date: November 1, 2007
Issued by: Center for Biologics Evaluation and Research
Topic(s): Vaccines
Status: Final
Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry
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 In addition, this guidance finalizes the draft guidance of the same title dated February 2005.
Download the Guidance Document
