Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications to assist manufacturers and/or sponsors in the development and testing of deoxyribonucleic acid [DNA) vaccines to prevent infectious diseases. The draft guidance, when finalized, will update and replace the guidance document entitled Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications dated 12/96. To download the guidance, click here. To view this notice, click here.
