Notice2022-23016
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry, Availability
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Published
October 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs." This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as "topical products"). This draft guidance document provides recommendations for physicochemical and structural (collectively, "Q3") characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)).
Full Text
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<title>Federal Register, Volume 87 Issue 204 (Monday, October 24, 2022)</title>
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[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64230-64232]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1864]
Physicochemical and Structural (Q3) Characterization of Topical
Drug Products Submitted in Abbreviated New Drug Applications; Draft
Guidance for Industry, Availability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the availability of a draft guidance for industry entitled
``Physicochemical and Structural (Q3) Characterization of Topical Drug
Products Submitted in ANDAs.'' This draft guidance is intended to
assist applicants who submit abbreviated new drug applications (ANDAs)
for liquid-based and/or other semisolid products applied to the skin,
including integumentary and mucosal (e.g., vaginal) membranes (referred
to as ``topical products''). This draft guidance document provides
recommendations for physicochemical and structural (collectively,
``Q3'') characterizations that can be used to identify the dosage form
of a proposed generic (test) topical product, and to describe
properties of the drug product that may be critical to its performance
(to support a demonstration of bioequivalence (BE)).
DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 64231]]
information, or other information that identifies you in the body of
your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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-2022-D-1864 for ``Physicochemical and Structural (Q3)
Characterization of Topical Drug Products Submitted in ANDAs.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Susan Levine, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Physicochemical and Structural (Q3) Characterization of
Topical Drug Products Submitted in ANDAs.'' This draft guidance is
intended to assist applicants who submit ANDAs for liquid-based and/or
other semisolid products applied to the skin, including integumentary
and mucosal (e.g., vaginal) membranes. This draft guidance document
provides recommendations for physicochemical and structural
(collectively, ``Q3'') characterizations that can be used: (1) to
identify the dosage form of a proposed generic (test) topical product
and (2) to describe properties of the drug product that may be critical
to its performance (to support a demonstration of BE). This draft
guidance does not address Q3 characterization of topical products for
purposes of product quality control.
Basic Q3 characterization of a topical product can be used to
describe its dosage form (e.g., an emulsion). The nomenclature used to
describe the dosage form of topical products (e.g., solutions,
suspensions, gels, lotions, creams, shampoos, ointments, pastes, etc.)
is not precisely defined by a systematic classification of the
compositional, physicochemical, or structural attributes of the drug
product. Consequently, for topical products, it may not be possible to
infer the Q3 attributes of a particular dosage form based upon the
dosage form nomenclature.
Comprehensive Q3 characterization of a topical product can be used
to establish a detailed profile of Q3 attributes that specifically
describes the nature of that product and identifies a collection of
attributes that describe the arrangement of matter (e.g., the
polymorphic form(s) of the active ingredient(s) and/or the pH of the
drug product) that may modulate the systemic or local availability of
the active ingredient(s) from the product. Because Q3 characterization
describes essential attributes of a drug product that may be critical
to its performance, differences in Q3 attributes between a test product
and the reference standard selected by FDA can indicate a risk that the
differences may impact the respective bioavailability and/or BE of the
two products. Conversely, a demonstration that there are no differences
in Q3 attributes between a test and reference standard substantially
mitigates the risk of potential failure modes for BE that may otherwise
arise from any differences in Q3 attributes.
This draft guidance provides recommendations on the types of
characterizations that constitute a basic and comprehensive Q3
characterization. This draft guidance also describes the concepts of
``sameness,'' ``similarity,'' and ``difference'' in comparing Q3
characterizations of two topical products, and how a showing of ``Q3
sameness,'' ``Q3 similarity,'' or ``Q3 difference'' between a test
topical product and the reference standard may impact what additional
evidence may be recommended to demonstrate BE, as part of a comparative
product characterization-based approach.
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
``Physicochemical and Structural (Q3) Characterization of Topical Drug
Products Submitted in ANDAs.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if
[[Page 64232]]
it satisfies the requirements of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this draft guidance contains no collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for the submission of ANDAs have been approved under OMB
control number 0910-0001. Applicant submission of controlled
correspondence related to generic drug development and FDA approval is
approved under OMB control number 0910-0797. The collections of
information that support Good Laboratory Practice (GLP) for Nonclinical
Laboratory Studies have been approved under OMB control number 0910-
0119. The collections of information in 21 CFR part 320 for
``Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans'' have been
approved under OMB control number 0910-0014. The recordkeeping
requirement for Current Good Manufacturing Practice (CGMP) sample
retention in 21 CFR 211.170 has been approved under OMB control number
0910-0139.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23016 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P
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