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GUIDANCE DOCUMENT

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

Final

Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment

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.”


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.