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This article was originally published in The Gray Sheet

Executive Summary

FDA issues letter to firm during May 12 meeting outlining "final steps required for FDA action" on the company's PMA for the OraSure oral specimen collection device for use in HIV diagnosis. According to the company, agency staff indicated at the meeting that 40 of 57 issues raised in an FDA 483 inspection report were resolved ("The Gray Sheet" Feb. 28, p. 6)
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