[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35940-35942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry on Codevelopment of Two or More New 
Investigational Drugs for Use in Combination; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The FDA is announcing the availability of a guidance for 
industry entitled ``Codevelopment of Two or More New Investigational 
Drugs for Use

[[Page 35941]]

in Combination.'' This guidance is intended to assist sponsors in the 
codevelopment of two or more investigational drugs that have not been 
previously developed for any indication (i.e., ``new investigational 
drugs'') to be used in combination to treat a disease or condition. The 
guidance provides recommendations and advice on how to address certain 
scientific and regulatory issues that may arise during codevelopment of 
two or more new investigational drugs. It is not intended to apply to 
development of combinations of already approved drugs or to development 
of a single new investigational drug to be used in combination with an 
already approved drug or drugs. The guidance is not intended to apply 
to biological products regulated by the Center for Biologics Evaluation 
and Research or medical devices.

DATES: Submit either electronic or written comments on Agency guidance 
at any time.

ADDRESSES: Submit written requests for single copies of the 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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, Bldg. 22, Rm. 
4216, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
1114.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA is announcing the availability of a guidance for industry 
entitled ``Codevelopment of Two or More New Investigational Drugs for 
Use in Combination.'' The guidance is intended to assist sponsors in 
the codevelopment \1\ of two or more investigational drugs that have 
not been previously developed for any indication (i.e., ``new 
investigational drugs'') to be used in combination to treat a disease 
or condition. 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 to develop 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 indication.
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    \1\ The term codevelopment as used in the guidance refers to the 
concurrent development of two or more new investigational drugs that 
are intended to be used in combination to treat a disease or 
condition. A sponsor may elect to codevelop two or more new 
investigational drugs intended to be marketed as individual agents 
or to be used in combination as a fixed-combination or copackaged 
drug.
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    Because existing developmental and regulatory pathways focus 
primarily on assessment of the safety and effectiveness of a single new 
investigational drug acting alone, or in combination with an already 
approved drug, FDA believes guidance is needed to assist sponsors in 
the codevelopment of two or more new investigational drugs. This 
guidance is intended to describe a high-level, generally applicable 
approach. It describes the criteria for determining when codevelopment 
may be an appropriate option, makes recommendations about nonclinical 
and clinical development strategies, and addresses certain regulatory 
process issues. The guidance is not intended to apply to biological 
products regulated by the Center for Biologics Evaluation and Research 
or medical devices.
    In the Federal Register of December 15, 2010 (75 FR 78259), FDA 
announced the availability of a draft of this guidance. FDA received a 
number of comments, including multiple comments seeking clarification 
of the scope and applicability of the guidance, the criteria for 
determining when codevelopment is appropriate, the evidentiary 
expectations for the individual new investigational drugs and their use 
in combination, and the types of regulatory submissions needed for 
codeveloped products. FDA has carefully considered these comments. The 
final guidance clarifies the criteria for determining when 
codevelopment is appropriate and elaborates on strategies for clinical 
development of the individual new investigational drugs and their use 
in combination. It also provides a detailed discussion of 
considerations for submitting Investigational New Drug Applications 
(INDs) and New Drug Applications (NDAs) . The final guidance clarifies 
the scope of the drugs to which it applies; it uses the term ``new 
investigational drug'' to refer to drugs that have not previously been 
developed for any indication. We have also revised the title of the 
guidance to reflect this term.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on development of two or more new 
investigational drugs for use in combination. 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 part 312 have been approved under 
OMB control number 0910-0014. The collections of information in 21 CFR 
part 314 have been approved under OMB control number 0910-0001. The 
collections of information in 21 CFR 201.56 and 201.57 have been 
approved under OMB control number 0910-0572. The collections of 
information in 21 CFR 310.305 and 314.80 have been approved under OMB 
control number 0910-0230. The collections of information in 21 CFR 
208.20, 208.24, and 314.70(b) have been approved under OMB control 
number 0910-0393.

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IV. 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: June 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14168 Filed 6-13-13; 8:45 am]
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