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Past Trials Can Provide Score For Temporary Ulcerative Colitis Endpoint, FDA Told

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Changes in how efficacy of ulcerative colitis drugs are measured are coming, but FDA GREAT2 workshop focused on criteria to use in the interim. An academic/industry consortium plans to submit proposed patient-reported outcome questionnaires for UC and Crohn’s disease to the agency Dec. 20.

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