FDA Announces Gastroenterology Public Workshop
The FDA Center for Drug Evaluation and Research, in cosponsorship with AGA, ACP, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and the Pediatric IBD Foundation, announced a two-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).” Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at NIH.
This workshop will provide a forum to consider issues related to endpoints that can support drug development in pediatric and adult IBD. The public workshop will be held on Oct. 21 and 22, 2013, from 8:30 a.m. to 5 p.m, in Bethesda, MD. Additional information, including how to register, can be found on the GREAT II website.
What can you expect to take away from the workshop? Jeffrey S. Hyams, MD, has published a summary on last year's GREAT meeting in AGA Washington Insider, a policy blog for GIs.