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Home-use HIV tests

This article was originally published in The Gray Sheet

Executive Summary

FDA review of Johnson & Johnson's application to market its Confide home HIV sample collection kit appears to be progressing following the review of the policy issues by an agency advisory panel in June ("The Gray Sheet" June 27, p. 6). Senior FDA executives are understood to have alerted the Clinton Administration that the agency sees no policy impediments to approving an over-the-counter HIV test kit. Speaking at a Sept. 19 meeting sponsored by FDA and the Parenteral Drugs Association, FDA Deputy Commissioner Mary Pendergast said that "as far as [FDA is] concerned, home-based collection kits for the HIV virus do not pose major regulatory difficulties if they are accurate and people can get counseling" from professional



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