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Nature Medicine 8, 1189 (2002)
doi:10.1038/nm1102-1189
Leukemia case triggers tighter gene-therapy controls
Laura Bonetta1
- Bethesda
A hastily convened advisory committee to the US Food and Drug Administration (FDA) ruled last month that gene-therapy trials of the kind that led to a leukemia-like illness in a French patient, and which were halted because of that case, should now continue. However, there must be increased monitoring for adverse events in patients, and they must receive modified informed consent forms to explain the chances of this side effect occurring.
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