Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for Treatment; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Irritable Bowel Syndrome—Clinical Evaluation of Products for Treatment.”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.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by May 24, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Ruyi He, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5122, Silver Spring, MD 20993-0002, 301-796-0910.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Irritable Bowel Syndrome—Clinical Evaluation of Products for Treatment.” This guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new product development for the treatment of IBS-D and IBS-C.

A content-valid PRO instrument that measures the clinically important signs and symptoms associated with each IBS subtype is the ideal primary efficacy assessment tool in clinical trials used to support labeling claims. However, at this time, an adequate instrument is not available. We recognize that it will take some time to develop adequate instruments and that in the meantime there is a great need to develop effective therapies for patients with IBS. Therefore, until the appropriate PRO instruments have been developed, this guidance recommends interim strategies for IBS clinical trial design and endpoints, and discusses the future development of PRO instruments for use in IBS clinical trials.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on clinical evaluation of products for the treatment of irritable bowel syndrome. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov .