美国FDA 指导原则 传染病适应症用质粒型DNA疫苗的工业考虑指南 英文原版.pdfVIP

Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852- 1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at /cber/guidelines.htm. For questions on the content of this guidance, contact the Office of Vaccines Research and Review at (301) 827-0655. U.S