82 FR 4890 - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 10 (January 17, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.

[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Notices]
[Pages 4890-4892]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4412]


Comparative Analyses and Related Comparative Use Human Factors 
Studies for a Drug-Device Combination Product Submitted in an 
Abbreviated New Drug Application; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Comparative Analyses and Related Comparative Use Human Factors 
Studies for a Drug-Device Combination Product Submitted in an ANDA.'' 
This draft guidance is intended to assist potential applicants who plan 
to develop and submit an abbreviated new drug application (ANDA) to 
seek approval of a generic combination product that includes both a 
drug constituent part and a delivery device constituent part.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance March 20, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food

[[Page 4891]]

and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4412 for ``Comparative Analyses and Related Comparative Use 
Human Factors Studies for a Drug-Device Combination Product Submitted 
in an ANDA.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, 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.

FOR FURTHER INFORMATION CONTACT: Andrew LeBoeuf, Office of Generic 
Drugs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-0503, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Comparative Analyses and Related Comparative Use Human 
Factors Studies for a Drug-Device Combination Product Submitted in an 
ANDA.''
    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) (the Hatch-Waxman Amendments) created, among other 
things, section 505(j) of the Federal Food, Drug and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 355(j)). Under section 505(j) of the FD&C Act, an 
ANDA applicant can rely on FDA's previous finding that the reference 
listed drug (RLD) is safe and effective so long as the ANDA applicant 
demonstrates that the proposed drug product and the RLD are the same 
with respect to active ingredient(s), dosage form, route of 
administration, strength, and, with certain exceptions, labeling. An 
ANDA must also include sufficient information to demonstrate that the 
proposed product is bioequivalent to the RLD, and that the ANDA meets 
the approval requirements relating to chemistry, manufacturing, and 
controls. An ANDA generally is not required to be the same as the 
listed drug it references in certain respects. For example, a generic 
drug generally can differ from its RLD in certain respects with regard 
to the device or with respect to inactive ingredients.
    Drug products that meet the approval requirements under section 
505(j) of the FD&C Act are generally considered by FDA to be 
therapeutically equivalent to their RLD. Products classified as 
therapeutically equivalent can be substituted with the full expectation 
that the generic product will produce the same clinical effect and 
safety profile as the RLD under the conditions specified in the 
labeling.
    These general principles apply to products submitted in ANDAs, 
including drug-device combination products. A generic drug-device 
combination product classified as therapeutically equivalent to the RLD 
can be expected to produce the same clinical effect and safety profile 
as the RLD under the conditions specified in labeling. This does not 
mean, however, that the proposed generic drug-device combination 
product and its RLD need to be identical in all respects. FDA 
recognizes that an identical design may not always be feasible and, in 
certain instances, differences in the design of the user interface for 
a generic drug-device combination product as compared to the RLD may 
exist without precluding approval of the generic combination drug-
device product under an ANDA. In some instances in which differences 
exist, certain additional information and/or data relating to the user-
interface of the proposed generic drug-device combination product, such 
as data from comparative use human factors studies, may be appropriate 
to support approval of the proposed product in an ANDA. The extent to 
which differences between the proposed product and the RLD affect the 
approvability of the proposed ANDA product will be evaluated on a case-
by-case basis.
    This draft guidance provides general principles, including 
recommendations on threshold analyses, which are intended to assist 
potential applicants in the identification and the assessment of 
differences in the design of the user interface of a proposed generic 
drug-device combination product when compared to the user interface for 
its RLD.
    This draft guidance also provides recommendations on the design and 
conduct of comparative use human factors studies that may help 
applicants determine whether design differences identified between the 
proposed generic drug-device combination product and its RLD would 
preclude approval as an ANDA under the FD&C Act.
    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 current thinking of FDA on ``Comparative 
Analyses and Related Comparative Use Human Factors Studies for a Drug-
Device Combination Product Submitted in an ANDA.'' It does not 
establish any rights for any

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person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00795 Filed 1-13-17; 8:45 am]
 BILLING CODE 4164-01-P