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ACTIVATED CHARCOAL OTC FEEDBACK MEETING TENTATIVELY SLATED

This article was originally published in The Tan Sheet

Executive Summary

ACTIVATED CHARCOAL OTC FEEDBACK MEETING TENTATIVELY SLATED with FDA for March 22 to discuss study protocols submitted by Kramer Labs and Requa to determine the efficacy of activated charcoal in relieving gastrointestinal distress. Both companies requested "OTC feedback" meetings with the agency to evaluate protocols developed in response to FDA's October 1993 final monograph on OTC digestive aids, which did not include activated charcoal due to a lack of sufficient data supporting efficacy ("The Tan Sheet" Oct. 25, 1993, p. 15).
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