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GUIDANCE DOCUMENT

Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment June 2012

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0146
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of irritable bowel syndrome (IBS). IBS diagnosis and assessment of clinical status depend mainly on an evaluation of IBS signs and symptoms that are known to the patient. Capturing all of the clinically important signs and symptoms associated with IBS in a reliable measure of treatment benefit can be challenging. The guidance for industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PRO guidance)3 defines the term treatment benefit as “[t]he effect of treatment on how a patient survives, feels, or functions.”

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