Notice2023-07770
Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability
Primary source
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Published
April 13, 2023
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs" (Revision 2). This draft guidance (Revision 2) revises the Revision 1 draft guidance of the same name, which was announced in the Federal Register on October 10, 2018. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA).
Full Text
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<title>Federal Register, Volume 88 Issue 71 (Thursday, April 13, 2023)</title>
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[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22456-22457]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07770]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1254]
Assessing Adhesion With Transdermal and Topical Delivery Systems
for Abbreviated New Drug Applications; Revised Draft Guidance for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the availability of a revised draft guidance for industry entitled
``Assessing Adhesion With Transdermal and Topical Delivery Systems for
ANDAs'' (Revision 2). This draft guidance (Revision 2) revises the
Revision 1 draft guidance of the same name, which was announced in the
Federal Register on October 10, 2018. This revised draft guidance
provides recommendations for the design and conduct of studies
evaluating the adhesion performance of a transdermal or topical
delivery system (collectively referred to as TDS). Depending on the
objectives of a generic TDS product development program, applicants may
choose to evaluate TDS adhesion in studies performed to evaluate TDS
adhesion only, or in studies performed with a combined purpose (e.g.,
for the simultaneous evaluation of adhesion and bioequivalence (BE)
with pharmacokinetic (PK) endpoints). The recommendations in this
revised draft guidance relate to studies submitted in support of an
abbreviated new drug application (ANDA).
DATES: Submit either electronic or written comments on the draft
guidance by June 12, 2023 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 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 2016-D-1254 for ``Assessing Adhesion With Transdermal and Topical
Delivery Systems for 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.
[[Page 22457]]
<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 this
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 guidance document.
FOR FURTHER INFORMATION CONTACT: Melissa Mannion, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 301-
796-2747.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Assessing Adhesion With Transdermal and Topical
Delivery Systems for ANDAs'' (Revision 2). This revised draft guidance
(Revision 2) revises the Revision 1 draft guidance of the same name,
which was announced in the Federal Register on October 10, 2018 (83 FR
50942). FDA received five comments on the revised draft guidance
(Revision 1), which were considered before publication of this revised
draft guidance (Revision 2).
This revised draft guidance (Revision 2) provides recommendations
for the design and conduct of studies evaluating the adhesion
performance of a TDS submitted in support of an ANDA. Depending on the
objectives of a TDS product development program, applicants may choose
to evaluate TDS adhesion in studies performed to evaluate TDS adhesion
only or in studies performed with a combined purpose (e.g., for the
simultaneous evaluation of adhesion and BE with PK endpoints). FDA
recommends that applicants consult this revised draft guidance
(Revision 2) in conjunction with any relevant product-specific
guidances for industry when considering the design and conduct of
studies that may be appropriate to support the BE of a proposed generic
TDS product to its reference listed drug and/or reference standard
product.
Specifically, in response to the comments received from industry,
FDA is clarifying the following components of the guidance. When
recording measurements of TDS adhesion, applicants may use appropriate
methods (e.g., a trained visual assessment and/or dot matrix templates)
and are encouraged to explore the use of alternative scales (other than
the five-point adhesion scale) to estimate the percentage of the entire
TDS surface area that is adhered to the skin. At each adhesion
assessment time point, applicants should also record photographic
evidence showing the extent of TDS adhesion to the skin. Because
percent adhesion can span a range and yet be classified as a single
score, the photographic evidence can be used to support the visual
observation of the percent adhesion reported at each time point and is
not intended to be used for automated or photometric analysis at this
time. Additional clarity is also provided related to the statistical
analysis of data. Finally, FDA recommends that an applicant who seeks
to use an alternative approach to FDA's recommendations for the design
and conduct of studies evaluating the adhesion performance of a TDS to
contact the Agency to discuss the proposed alternative approach to
evaluate adhesion performance for that particular drug product.
This revised draft guidance (Revision 2) is being issued consistent
with FDA's good guidance practices regulation (21 CFR 10.115). The
revised draft guidance, when finalized, will represent the current
thinking of FDA on ``Assessing Adhesion With Transdermal and Topical
Delivery Systems for 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 it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this revised draft guidance (Revision 2) 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 in 21 CFR part 314
have been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.regulations.gov">https://www.regulations.gov</a>, or <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>.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07770 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P
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