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C.B. Fleet enema response-time data inadequate, FDA says: double-blind trials needed.

This article was originally published in The Tan Sheet

Executive Summary

GLYCERIN ENEMA RESPONSE TIMES: RANDOMIZED, DOUBLE-BLINDED STUDIES NEEDED to support a bowel movement response time of two to 15 minutes, FDA told C.B. Fleet Co. in a July 24 letter. The agency was responding to November 1993 and March 1994 submissions from C.B. Fleet requesting that the tentative final monograph for OTC laxatives be amended to include the statement that a glycerin enema "generally produces a bowel movement in two to 15 minutes."
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