PRO Instruments For IBDs On Horizon
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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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.
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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