[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Notices]
[Page 58312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc07-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0367]
Draft Guidance for Industry on Antibacterial Drug Products: Use
of Noninferiority Studies to Support Approval; 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availability of a draft guidance for industry entitled ``Antibacterial
Drug Products: Use of Noninferiority Studies to Support Approval.'' The
purpose of this guidance is to inform industry of FDA's current
thinking regarding appropriate clinical study designs to evaluate
antibacterial drugs, and to ask sponsors to amend ongoing or completed
studies accordingly. This guidance is in response to a number of public
discussions in recent years regarding the use of active-controlled
studies designed to show noninferiority as a basis for approval of
antibacterial drug products.
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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 December 14, 2007.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. 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on the draft guidance to the Division of Dockets Management (HFA-305),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.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Edward Cox, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6412, Silver Spring, MD 20993-0002, 301-796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Antibacterial Drug Products: Use of Noninferiority Studies
to Support Approval.'' Most antibacterial drugs have been approved
based on active-controlled noninferiority trials. There have been a
number of public discussions in recent years on the use of
noninferiority studies to support regulatory approval of antibacterial
drug products. Some of these discussions have focused on specific
diseases such as acute bacterial sinusitis, acute bacterial otitis
media, and acute bacterial exacerbation of chronic bronchitis. These
public discussions have contributed to FDA's evolving understanding of
the science of clinical trials and, in particular, the appropriate role
of active-controlled studies designed to show noninferiority in the
development of antibacterial drug products.
This draft guidance recommends that sponsors provide justification
for the treatment effect size and the proposed noninferiority margin
for all antibacterial development programs for which approval will rely
on noninferiority studies.
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 the use of
noninferiority studies to support approval of antibacterial drug
products. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively, and the collection of information under the guidance for
industry Special Protocol Assessment has been approved under OMB
control number 0910-0470.
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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: October 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20282 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S