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PRO Instruments For IBDs On Horizon

Executive Summary

At least portions of patient-reported outcome instruments for ulcerative colitis and Crohn’s disease could be ready for use by the end of 2013.

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

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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PDUFA V framework to involve patients in the creation of the risk-benefit criteria for various diseases kicks off before the legislation is even enacted.

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