Notice: Draft Guidance for Industry on Non-Inferiority Clinical Trials; 
Availability

Federal Register: March 1, 2010 (Volume 75, Number 39)           
                  Page 9228-9229

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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availability of a draft guidance for industry entitled ``Non-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 This draft guidance provides sponsors 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 The draft 
guidance offers advice on when NI studies can be interpretable, how to 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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Submit written comments on the draft guidance to the Division of 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.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]
BILLING CODE 4160-01-S