The United States Food and Drug Administration (USFDA) has announced an immediate review of new clinical trials that involve sending American citizens\u2019 living cells to China and other hostile countries for genetic engineering and subsequent infusion back into US patients \u2014 sometimes without their knowledge or consent.<\/p>\n
This follows mounting evidence that some trials failed to inform participants about the international transfer and manipulation of their biological material, and may have exposed Americans\u2019 sensitive genetic data to misuse by foreign governments, including adversaries, the FDA said. \u201cThis practice was made possible by a data security rule finalised under the Biden administration in December 2024 and implemented in April 2025 by the US Department of Justice,\u201d the note said. The agency said it was reviewing all clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.<\/p>\n
The agency is also working with the National Institutes of Health (NIH) to ensure that no federally funded research is compromised by these practices. Additional enforcement and policy measures could be forthcoming.<\/p>\n
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Published on June 29, 2025 <\/p>\n","protected":false},"excerpt":{"rendered":"The United States Food and Drug Administration (USFDA) has announced an immediate review of new clinical trials that…\n","protected":false},"author":3,"featured_media":24959,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[22320,5564,16254,22319,815,159,67,132,68,12728],"class_list":{"0":"post-24958","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-genetics","8":"tag-clinical-trial","9":"tag-dna","10":"tag-export","11":"tag-genetic-material","12":"tag-genetics","13":"tag-science","14":"tag-united-states","15":"tag-unitedstates","16":"tag-us","17":"tag-usfda"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/114767678822508279","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/24958","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=24958"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/24958\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/24959"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=24958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=24958"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=24958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}