Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II), October 21 - 22, 2013, National Institutes of Health
On October 21 – 22, 2013, FDA is conducting a public workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II). This workshop will address endpoints for registration trials, and also address issues related to selection of endpoints and assessment of methodologies in registration trials for products intended to treat adult and/or pediatric inflammatory bowel disease.
This website will be updated as meeting materials are developed.
Federal Register Notice: