[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Notices]
[Pages 13765-13766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0146]


Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical 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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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availability of a draft guidance for industry entitled ``Irritable 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 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

[[Page 13766]]

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.

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6310 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S