Notice2021-14202
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications; Draft Guidance for Industry; Availability
Primary source
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Published
July 2, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications." Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as new drug applications (NDAs) or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration. When final, this draft guidance will expand upon the recommendation for in vivo adhesion studies in section V., Special Topics, subsection A., Product Adhesion Considerations, in the draft guidance for industry Transdermal and Topical Delivery Systems--Product Development and Quality Considerations issued on November 21, 2019.
Full Text
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<title>Federal Register, Volume 86 Issue 125 (Friday, July 2, 2021)</title>
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[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35304-35305]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14202]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2323]
Assessment of Adhesion for Topical and Transdermal Systems
Submitted in New Drug Applications; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``Assessment
of Adhesion for Topical and Transdermal Systems Submitted in New Drug
Applications.'' Transdermal delivery systems are designed to deliver a
drug across the skin and into systemic circulation, whereas topical
delivery systems are designed to deliver the drug to local tissue.
There is pharmaceutical and other stakeholder interest in the
development of new transdermal and topical products, and this guidance
provides recommendations on the clinical assessment of adhesion for
such products that will be submitted as new drug applications (NDAs) or
supplemental new drug applications. This guidance provides additional
study design and methodology recommendations on conducting in vivo
adhesion studies. This guidance takes these developments into
consideration. When final, this draft guidance will expand upon the
recommendation for in vivo adhesion studies in section V., Special
Topics, subsection A., Product Adhesion Considerations, in the draft
guidance for industry Transdermal and Topical Delivery Systems--Product
Development and Quality Considerations issued on November 21, 2019.
DATES: Submit either electronic or written comments on the draft
guidance by August 31, 2021 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
[[Page 35305]]
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-2020-D-2323 for ``Assessment of Adhesion for Topical and
Transdermal Systems Submitted in New Drug Applications.'' 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 that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Margaret Kober, Center for Drug
Evaluation and Research (HFD-580), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 5376, Silver Spring, MD 20993-0002,
301-796-0934.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Assessment of Adhesion for Topical and Transdermal Systems
Submitted in New Drug Applications.'' This draft guidance provides
recommendations on the clinical assessment of the adhesive properties
of topical and transdermal delivery systems (collectively referred to
as TDS) intended for submission in an NDA or supplemental NDA. The
amount of drug delivered into and through the patient's skin from a TDS
is dependent, in part, on the ability of the TDS to remain in direct
contact with the skin (adhesive properties). Adhesive properties are
clinically important as a loss of TDS adhesion during wear can reduce
the amount of drug delivered to the patient, potentially compromising
effectiveness. Additionally, partial or full detachment of a TDS from a
patient's skin may result in unintentional exposure of the drug to
others, potentially compromising safety. This draft guidance includes
key considerations for the design of the TDS adhesion clinical study,
including the selection of endpoints and FDA's current thinking on
acceptable adhesion performance in the in vivo setting.
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 ``Assessment
of Adhesion for Topical and Transdermal Systems Submitted in New Drug
Applications'' and will supersede in vivo recommendations in section
V., Special Topics in the draft guidance for industry ``Transdermal and
Topical Delivery Systems--Product Development and Quality
Considerations'' issued on November 21, 2019 (84 FR 64319). 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 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 in 21 CFR part 314 have been approved under OMB control
number 0910-0001, and the collections of information for the electronic
submission of drug establishment registration and drug listing
information have been approved under OMB control number 0910-0045.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <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> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14202 Filed 7-1-21; 8:45 am]
BILLING CODE 4164-01-P
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