FDA seeking input on endpoints for IBD

FDA's Center for Drug Evaluation and Research is holding a public workshop on Oct. 21-22 to discuss endpoints for registrational trials for drug development in pediatric and adult inflammatory bowel diseases (IBDs). Topics for the workshop will include how to measure and define treatment benefit for Crohn's disease as well as the role of existing and future clinical outcome assessments, including patient-reported outcome measures. The workshop is co-sponsored by a number of trade groups including the American College of Gastroenterology and the Pediatric IBD Foundation. ...