The American College of Gastroenterology (ACG), in partnership with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, the American Gastroenterological Association, the Crohn’s and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).” The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease.
The workshop’s goal is to come up with a consensus of “endpoints,” or markers the FDA can use when reviewing the safety/efficacy of a potential drug. These can include relieving symptoms of a disease, curing the disease, improving daily living function, etc.
The public workshop will be held on March 30 and 31, 2015, from 8:30 a.m. to 5 p.m.at the FDA’s White Oak Campus in Silver Spring, Maryland.
This is the third time ACG has co-hosted this event with the FDA and other societies.