美国FDA 指导原则 参加血浆置换和免疫计划的来源血浆捐献者的行业知情同意建议指南 英文原版.pdfVIP

Guidance for Industry Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs 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 Division of Blood Applications, Office of Blood Research and Review (OBRR