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Imatron Takes Issue With FDA Charge Of Web-Related Off-Label Promotion

This article was originally published in The Gray Sheet

Executive Summary

Imatron says it is willing to sever the link between its web site and that of its former subsidiary, HeartScan San Francisco, if FDA deems such action necessary to comply with agency advertising regulations. However, the company disagrees with FDA's contention that the site promotes an "off-label" use.

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