Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment." This guidance addresses the following three main topics regarding irritable bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea (IBS-D) and IBS with constipation (IBS-C): The evolution of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design and endpoints, and the future development of patient-reported outcome (PRO) instruments for use in IBS clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new product development for the treatment of IBS.