Business · 23/03/2010

FDA Releases Draft Guidance for Industry on IBS Clinical Evaluation of Products for Treatment

The Food and Drug Administration (FDA) has released a draft guidance for the pharmaceutical industry on evaluating products for treating Irritable Bowel Syndrome (IBS) with diarrhea (IBS-D) and IBS with constipation (IBS-C). The guidance aims to help companies design clinical trials and develop patient-reported outcome instruments for IBS treatments.