FDA resists regulatory role in gene tests

Wadman, Meredith
November 1996
Nature;11/14/1996, Vol. 384 Issue 6605, p101
Academic Journal
Discusses the controversy surrounding the decision by a government-sponsered task force to recommend that the US Food and Drug Administration (FDA) regulate genetic tests. The task force comprised of the National Institutes of Health and the Department of Energy Task Force on Genetic Testing; The reasons for resistance from the FDA; The introduction of genetic screening for breast and ovarian cancers into the commercial market; The Clinical Laboratory Improvement Amendments.


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