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OTC drugs of abuse test kit guidance slated for FDA panel review Sept. 25.

This article was originally published in The Tan Sheet

Executive Summary

OTC DRUGS OF ABUSE TEST GUIDANCE SLATED FOR REVIEW SEPT. 25 by FDA's Clinical Chemistry & Clinical Toxicology Devices Panel. FDA developed the draft points-to-consider document on approval requirements for home drugs of abuse tests in response to the "considerable" interest expressed by manufacturers in bringing to market drugs of abuse tests that consumers can perform on their own, the agency states. The draft document, released Aug. 25, covers only in vitro diagnostics that use urine samples, "the matrix with which there has been the most experience," the agency says.
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