美国FDA 指导原则 传染病适应症预防和治疗疫苗开发毒性研究的行业考虑指南 英文原版.pdfVIP

Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic 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 CBER Division of Vaccines and