Regulacje i polityka gospodarcza · 27/12/1996

Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications; Availability

The Food and Drug Administration (FDA) is announcing the availability of a points to consider (PTC) document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications.'' The PTC document is intended to provide manufacturers with preliminary guidance regarding the manufacture and preclinical evaluation of plasmid deoxyribonucleic acid (DNA) vaccines intended for clinical studies in preventive infectious disease indications and to assist manufacturers in the preparation of investigational new drug (IND) applications for use of these vaccines. This document is also intended to assist manufacturers with their product development plans for preventive vaccines for infectious diseases.