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This article was originally published in The Gray Sheet

Executive Summary

Files additional materials with FDA in support of the company's premarket approval application for OraSure, an oral specimen collection device for use in detection of antibodies for HIV-1. The filing, which the firm submitted in response to concerns raised at a Dec. 18 FDA blood products advisory committee meeting ("The Gray Sheet" Dec. 21, 1992, p. 5) and subsequent sessions with FDA staff, "covers proposed labeling, a mechanism for confirmation of positive screening tests, procedures for subject counseling, and training of specimen collection personnel," according to Adolph Ferro, Epitope president and chief executive officer.



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