[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Page 78259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0616]


Draft Guidance for Industry on Codevelopment of Two or More 
Unmarketed Investigational Drugs for Use in Combination; 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availability of a draft guidance for industry entitled ``Codevelopment 
of Two or More Unmarketed Investigational Drugs for Use in 
Combination.'' This guidance is intended to assist sponsors in the 
codevelopment of two or more novel (not previously marketed) drugs to 
be used in combination to treat a disease or condition. This guidance 
provides recommendations and advice on how to address certain 
scientific and regulatory issues that will arise during codevelopment. 
The guidance is not intended to apply to development of fixed-dose 
combinations of already marketed drugs or to development of a single 
new investigational drug to be used in combination with an approved 
drug or drugs. The guidance is also not intended to apply to vaccines, 
gene or cellular therapies, blood products, or medical devices.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Colleen Locicero, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm 4216, Silver Spring, MD 20993-0002, 301-
796-1114.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Codevelopment of Two or More Unmarketed Investigational 
Drugs for Use in Combination.'' The guidance is intended to assist 
sponsors interested in developing two or more novel (not previously 
marketed) drugs to be used in combination. Recent scientific advances 
have increased our understanding of the pathophysiological processes 
that underlie many complex diseases, such as cancer, cardiovascular 
disease, and infectious diseases. This increased understanding has 
provided further impetus for new therapeutic approaches that rely 
primarily or exclusively on combinations of drugs directed at multiple 
therapeutic targets to improve treatment response and minimize 
development of resistance. In settings in which combination therapy 
provides significant therapeutic advantages, there is growing interest 
in the development of combinations of investigational drugs not 
previously developed for any purpose.
    Because the existing developmental and regulatory paradigm focuses 
primarily on assessment of the effectiveness and safety of a single new 
investigational drug acting alone, or in combination with an approved 
drug, FDA believes guidance is needed to assist sponsors in the 
codevelopment of two or more unmarketed drugs. This guidance is 
intended to describe a high-level, generally applicable approach to 
codevelopment of two or more unmarketed drugs. It describes the 
criteria for determining when codevelopment is an appropriate option, 
makes recommendations about nonclinical and clinical development 
strategies, and addresses certain regulatory process issues. The 
guidance does not apply to vaccines, gene or cellular therapies, or 
blood products.
    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 companion 
diagnostic devices. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: December 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31426 Filed 12-14-10; 8:45 am]
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