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Medical Letter on the CDC & FDA

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Legal Issues



FDA May Bar Doctor from Gene Research



December 31st, 2000

A University of Pennsylvania scientist who led a gene therapy research project in which a teenager died could be permanently barred from testing drugs on humans under a proceeding started by the U.S. Food and Drug Administration.

The FDA notified Dr. James M. Wilson of the University of Pennsylvania on November 30, 2000, that the agency was starting a proceeding "to determine whether you should be disqualified" from experimental drug research on human subjects.

Larry Bachorik, an FDA spokesman, said on December 11, 2000, that the process could result in Wilson being barred for life from conducting human subject research in this country.

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Source: Medical Letter on the CDC & FDA (2000-12-31)

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