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Psyllium

Executive Summary

FDA OTC Drug Evaluation Director Gilbertson informs Procter & Gamble that a study on psyllium as a cholesterol-lowering agent proposed in a March 23 letter appears to "provide adequate data for statistical analysis of endpoint efficacy and safety variables, dietary and test drug compliance data." However, Gilbertson notes that the study will not provide information on dose response or the mechanism of action, two questions of interest to FDA.

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