US EditionFDA Says Americans' DNA Sent to Foreign Labs in Clinical Trials
- On June 18, 2025, the FDA began promptly examining clinical trials that transfer Americans' living cells overseas—especially to China—for genetic modification and subsequent reinfusion.
- This review responds to an exemption finalized in late 2024 and implemented in April 2025 that allowed export of U.S. biological samples, including DNA, sometimes involving entities linked to Chinese interests.
- The FDA is suspending new trials that involve sending cells abroad and now requires companies to provide clear disclosure, obtain proper ethical approval, and ensure that sensitive biological samples are managed within the United States amid concerns about patient awareness and data protection.
- NIH Director Bhattacharya confirmed a portfolio-wide NIH review to check if federally funded trials used this exemption, emphasizing patient privacy and restoring confidence in biomedical research.
- The FDA emphasized its commitment to safeguarding patients, rebuilding public confidence, maintaining U.S. leadership in biomedical research, and preventing any disruption to federally supported scientific studies due to improper practices.
44 Articles
44 Articles
FDA Says Americans’ DNA Sent to Foreign Labs in Clinical Trials
by Thérèse Boudreaux The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ genetic data to international labs. Based on “mounting evidence,” the FDA said, some U.S. companies did not inform trial participants that their living cells were sent to foreign labs, including in China, for genetic engineering before reinfusion into patients. “The previous administration turned a blin…
FDA Says Americans’ DNA Sent to Foreign Labs in Clinical Trials | The Star News Network
by Thérèse Boudreaux The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ genetic data to international labs. Based on “mounting evidence,” the FDA said, some U.S. companies did not inform trial participants that their living cells were sent to foreign labs, including in China, for genetic engineering before reinfusion into patients. “The previous administration turned a blin…
FDA Halts Trials Exporting Americans' Cells To Hostile Countries For Genetic Engineering - CRISPR Therapeutics (NASDAQ:CRSP), Caribou Biosciences (NASDAQ:CRBU)
The U.S. Food and Drug Administration (FDA) on Wednesday initiated an immediate review of clinical trials that involved sending Americans’ living cells to China and other foreign adversaries for genetic engineering and subsequent infusion back into U.S. patients, sometimes without their knowledge or consent. The move comes amid growing concern over the security and ethics of cross-border biomedical research and the handling of sensitive genetic …
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