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DIRECT ACCESS DIAGNOSTICS SUBMITS DATA TO FDA ON "HOME ACCESS HIV TESTING

This article was originally published in The Gray Sheet

Executive Summary

DIRECT ACCESS DIAGNOSTICS SUBMITS DATA TO FDA ON "HOME ACCESS HIV TESTING and counseling service," the Johnson & Johnson company says. The data supplements information on file at the agency in a premarket approval application submitted in late 1987 by now- defunct University Hospital Labs for the AIDS Check system. In 1990, FDA's Blood Products Advisory Committee recommended against approval of AIDS Check for over-the-counter sales ("The Gray Sheet" July 23, 1990, p. 5).
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