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Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical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availability of a draft guidance for industry entitled ``Irritable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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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INFORMATION section for electronic access to the draft guidance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