[Federal Register Volume 75, Number 39 (Monday, March 1, 2010)]
[Notices]
[Pages 9228-9229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0075]
Draft Guidance for Industry on Non-Inferiority Clinical Trials;
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availability of a draft guidance for industry entitled ``Non-
Inferiority Clinical Trials.'' This draft guidance provides sponsors
and review staff in the Center for Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation and Research (CBER) with the
agency's interpretation of the underlying principles involved in the
use of non-inferiority (NI) study designs to provide evidence of the
effectiveness of a drug or therapeutic biologic product. The draft
guidance offers advice on when NI studies can be interpretable, how to
choose the NI margin, and how to analyze the results.
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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 June 1, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, or to
the Office of Communication, Outreach and Development, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. 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Submit written comments on the draft guidance to the Division of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.
[[Page 9229]]
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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.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:
Robert Temple, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4212,
Silver Spring, MD 20993-0002, 301-796-2270; or
Robert T. O'Neill, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3554,
Silver Spring, MD 20993-0002, 301-796-1700; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Non-Inferiority Clinical Trials.'' The draft guidance
includes four parts. The first part is a discussion of regulatory,
study design, scientific, and statistical issues associated with the
use of non-inferiority studies when these are used to establish the
effectiveness of a new drug or therapeutic biologic product. The second
part focuses on some of these issues in more detail, notably the
quantitative analytical and statistical approaches used to determine
the non-inferiority margin for use in NI studies, as well as the
advantages and disadvantages of available methods. The third part
addresses commonly asked questions about NI studies and provides
practical advice about various approaches. The fourth part includes
five examples of successful and unsuccessful efforts to define non-
inferiority margins and conduct NI 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 non-
inferiority clinical trials. 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, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.
Dated: February 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4109 Filed 2-26-10; 8:45 am]
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