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FDA Says Americans' DNA Sent to Foreign Labs in Clinical Trials
- On June 21, 2025, the FDA halted new clinical trials sending Americans' living cells abroad for genetic modification, launching an immediate review of such trials.
- This action targets a disputed exemption from late 2024 that permitted U.S. companies to send Americans’ biological materials, such as genetic data, to foreign laboratories for analysis and manipulation—often without obtaining informed consent from the patients involved.
- Dr. Marty Makary, head of the FDA, condemned the previous administration for allowing this practice and highlighted priorities such as patient protection, rebuilding public trust, and maintaining U.S. leadership in biomedical research.
- The FDA now mandates that companies provide clear disclosure, secure ethical approval, and conduct biological sample processing within the United States, preventing any new studies that do not comply with these rigorous requirements.
- The FDA coordinates with NIH, which is reviewing its research portfolio to determine if federally funded trials utilized the exemption, aiming to secure the integrity of U.S. biomedical research.
50 Articles
50 Articles
FDA Halts Trials That Send Americans' DNA to China, 'Other Hostile Countries'
“The previous administration turned a blind eye and allowed American DNA to be sent abroad - often without the knowledge or understanding of trial participants,” said FDA Commissioner Dr. Marty Makary.
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There were two companies in cities associated with DuPage County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).This is a 50% decrease from the number of companies cited in the previous quarter.The citations in the county include: You do not have or have not implemented product specifications and an affirmativ…
FDA halts Biden-era program of sending Americans' DNA to China for genetic engineering
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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…
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