# FDA Posts Guidance for Clinical Evaluation of IBS Drugs



## Jeffrey Roberts (Apr 15, 1987)

The FDA announced the availability of a guidance intended to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of IBS, specifically the IBS indications for IBS with diarrhea and IBS with constipation.The guidance describes the evolution of patient-reported outcome (PRO) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial design recommendations that sponsors may apply to IBS clinical trialshttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM205269.pdfSource: AGA e-Digest June 14, 2012


----------

