[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50825-50826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19906]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0449]
Draft Guidance for Industry on Integrated Summary of
Effectiveness; 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availability of a draft guidance for industry entitled ``Integrated
Summary of Effectiveness.'' This draft guidance describes how an
integrated summary of effectiveness (ISE) should be prepared by
industry for new drug applications (NDAs) and biologics license
applications (BLAs). This guidance, when final, will supersede section
G, Integrated Summary of Effectiveness Data, of the 1988 guidance on
``Format and Content of the Clinical and Statistical Sections of an
Application'' (Clin-Stat guidance). This guidance also incorporates the
conceptual framework of section 2.7.3, Summary of Clinical Efficacy,
from the International Conference on Harmonisation (ICH) guidance for
industry ``M4E The CTD --Efficacy.'' This guidance is intended to
improve the quality of product applications by describing what efficacy
information should be submitted so that FDA can make a regulatory
decision on an application.
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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 October 27, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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; or
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research, 1401 Rockville
Pike, Rockville, MD 20852-1448. The guidance may also be obtained from
the Center for Biologics Evaluation and Research by mail by calling 1-
800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document. 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.
FOR FURTHER INFORMATION CONTACT:
Howard Chazin, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6470,
Silver Spring, MD 20993-0002, 301-796-0700; or
Leonard Wilson, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1401 Rockville Pike, suite 576N,
Rockville, MD 20852, 301-827-1053.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Integrated Summary of Effectiveness.'' This draft guidance
describes how an ISE should be prepared by industry for NDAs and BLAs.
The ISE has been required as part of an NDA submission (21 CFR
314.50(d)(5)(v)) since 1985, but the regulation does not describe the
specific components of the ISE. The Clin-Stat guidance provides a
description of what FDA recommends be included in an ISE. However,
since the Clin-Stat guidance was published, several International
Conference on Harmonisation guidances, including the ICH guidances for
industry ``E3 Structure and Content of Clinical Study Reports,'' ``E10
Choice of Control Group and Related Issues in Clinical Trials,'' and
``M4E The CTD--Efficacy,'' have provided further recommendations for
describing individual trials and providing results of efficacy
analyses. This guidance, when final, will supersede section G of the
Clin-Stat guidance to reflect FDA's current thinking regarding the
format and content of the ISE to provide a truly integrated analysis,
rather than a summary of efficacy results from individual clinical
trials, and to satisfy FDA regulatory requirements. Although there are
no corresponding regulations requiring an ISE for BLA submissions,
applicants are encouraged to provide these analyses.
Regarding the common technical document, the ISE is often confused
with the document included in Module 2, section 2.7.3, Summary of
Clinical Efficacy. Although one of the goals of the ISE is to summarize
the available effectiveness data, the ISE primarily is intended to be
an integrated analysis of these data, going beyond a simple summary.
The focus of the ISE is not on the detailed results of the individual
studies, which are described in individual study reports, but a
comprehensive, detailed, in-depth analysis that goes beyond individual
study results to examine the basis for the entire approach taken.
This draft guidance is being issued consistent with FDA's good
guidance
[[Page 50826]]
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the content
and format of the ISE. 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. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 314 have been approved
under 0910-0001. The collections of information for submission of data
in a BLA under 21 CFR 601.2 have been approved under 0910-0338.
III. 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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.
Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19906 Filed 8-27-08; 8:45 am]
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