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Zdrowie i gospodarka · 29/10/2007

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 document entitled "Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications" dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled "Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications" dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.

Source: Federal Register — Food and Drug AdministrationOpen original release →