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

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).