摘要：1什么是FDA及21CFR Part 11FDA是美国食品与药物管理局(Food and Drug Administration)的简称,创立于1906年,职责是确保美国本土生产或进口的食品、化妆品、药物、医疗设备和放射产品的安全,是美国历史最悠久的保护消费者为主要职能的联邦机构之一。
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