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In Brief: NDMA attapulgite trial

This article was originally published in The Tan Sheet

Executive Summary

NDMA attapulgite trial: FDA informs NDMA in a recent letter of an internal agency meeting on May 13 to address the trade association's proposal for analyzing data from its attapulgite trial. FDA's letter responds to a request for feedback on the design of the study, which will compare effectiveness of attapulgite and placebo in treating acute non-specific diarrhea. NDMA has nearly completed enrollment in the study. The study will evaluate subjects in Mexico and Jamaica who are found to have pathogen-negative stools. "The Tan Sheet" mistakenly reported (June 3, In Brief) that the pathogen-positive subgroup would be the central focus of the study...
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