Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee,
Meeting on November 17, 2011, from 8 a.m. to 5 p.m. (Day 2 of 2)

Agenda: On November 17, 2011, the committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5- hydroxytryptamine) receptor 4 agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation, constipation predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.