Zdrowie i gospodarka · 18/02/2005

Draft Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications" dated February 2005. The draft guidance document is intended to assist manufacturers and/or sponsors in the development and testing of deoxyribonucleic acid (DNA) vaccines to prevent infectious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 The draft guidance, when finalized, will update and replace the guidance document entitled "Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease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 December 1996.