太美医疗科技助力安领科生物完成FDA Gateway联调测试 加强药物警戒国际化运营能力

中国经济新闻网
Feb 24

近日,太美医疗科技药物警戒团队助力安领科生物完成FDA Gateway联调测试。此次联调测试的目标在于满足FDA最新监管要求,加强公司药物警戒国际化运营能力。2024年4月1日,美国FDA发布了关于电子提交新药临床研究申请(IND)安全报告的最终指南。指南规定:2026年4月1日之后,IND申请必须向FDA的不良事件报告系统(FAERS)提交满足E2B R3规范的SUSAR报告。目前,这些报告使用...

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