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LAXATIVE COMBINATION TIME-TO-RELIEF DATA SOUGHT BY FDA

This article was originally published in The Tan Sheet

Executive Summary

LAXATIVE COMBINATION TIME-TO-RELIEF DATA SOUGHT BY FDA in an April 4 letter to the Nonprescription Drug Manufacturers Association. FDA OTC Monograph Review Staff Director William Gilbertson, PharmD, explained in the letter that the agency is concerned that "time frames within which combination laxative products should be expected to work" are not addressed in the tentative final monograph for OTC laxative drug products. The agency is requesting the information, "preferably by June 1, 1994," for inclusion in the final monograph.
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