《FDA halts new clinical trials that export Americans’ cells to foreign labs in hostile countries for genetic engineering》

  • 来源专题:宁夏重点产业科技信息服务
  • 编译者: 刘 悦
  • 发布时间:2025-06-19
  • 美国食品药品监督管理局(FDA)于2025年6月18日宣布,立即审查涉及将美国公民的活细胞送往中国等敌对国家进行基因工程改造并随后输注回美国患者的新临床试验。这些试验中有部分未能告知参与者其生物材料被国际转移和操作的情况,可能使美国人的敏感基因数据暴露于外国政府(包括敌人)的滥用风险。这一做法源于拜登政府在2024年12月最终确定并于2025年4月由美国司法部实施的数据安全规则,该规则虽然对向关注国家传输敏感数据设置了出口控制,但拜登政府特别请求并批准了一项广泛豁免,允许美国公司将试验参与者的生物样本(包括DNA)送往海外进行处理。FDA局长Dr. Marty Makary表示,前任政府对此视而不见,允许在试验参与者不知情或不理解的情况下将美国DNA送出国门。FDA正在积极审查所有依赖此豁免的相关临床试验,以保护患者、恢复公众信任和维护美国生物医药研究的完整性和领导地位。
  • 原文来源:https://www.nih.gov/news-events/news-releases/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic-engineering
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