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In Brief: Home Access Health

This article was originally published in The Gray Sheet

Executive Summary

Home Access Health: FDA completes review of a premarket approval application for the firm's home-use HIV test system and finds no major deficiencies, Home Access says. The firm plans to forward a response to FDA in a matter of weeks to address "routine" issues raised by reviewers. The PMA, which has been under expedited review at the agency, was submitted at the end of May ("The Gray Sheet" June 5, p. 14). Manufacturing site inspections also have been scheduled, according to the firm. Home Access says it is prepared for production and expects to bring the test system to market in the first half of 1996. "The Gray Sheet" (Nov. 27, I&W-2) incorrectly referred to the company by its previous name, Anonymous Testing Service...



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