免疫毒性测试指南；可用性。美国卫生与公众服务部食品药品监督管理局。通知。
Immunotoxicity testing guidance; availability. Food and Drug Administration, HHS. Notice.
出版信息
Fed Regist. 1999 May 6;64(87):24408-9.
PMID:10558489
Abstract
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Immunotoxicity Testing Guidance." This guidance is intended to provide FDA reviewers and manufacturers with a coherent strategy for assessing whether testing for potential adverse effects involving medical devices or constituent materials and the immune system is needed. The guidance is also intended to aid in developing a systematic approach to such testing.
摘要
美国食品药品监督管理局（FDA）宣布提供题为《免疫毒性测试指南》的指南。本指南旨在为FDA审评人员和制造商提供一个连贯的策略，以评估是否需要对涉及医疗器械或组成材料与免疫系统的潜在不良反应进行测试。该指南还旨在帮助制定针对此类测试的系统方法。
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