March 17, 2000
Government Regulators Tighten Oversight of Gene-Therapy Trials
Federal regulators announced steps last week to increase oversight of the safety of gene-therapy trials. The announcement followed the death of 18-year-old Jesse Gelsinger in an experiment at the University of Pennsylvania last year, and findings that researchers underreported serious side effects in other gene-therapy studies.
The changes involve tougher enforcement of existing rules by the Food and Drug Administration and the National Institutes of Health.
Officials from both
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