Notice2023-11900
Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry; Availability
Primary source
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Published
June 5, 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 final guidance for industry entitled "Drug-Drug Interaction Assessment for Therapeutic Proteins." With the continued market growth and increased clinical use of therapeutic proteins, it is important to understand the nature of and the potential for drug-drug interactions (DDIs) with these products. The purpose of this guidance is to help sponsors of investigational new drug applications (INDs) and applicants of biologics license applications (BLAs) determine the need for DDI studies for a therapeutic protein by providing a systematic, risk-based approach. This guidance finalizes the draft guidance of the same title issued on August 10, 2020.
Full Text
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<title>Federal Register, Volume 88 Issue 107 (Monday, June 5, 2023)</title>
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[Federal Register Volume 88, Number 107 (Monday, June 5, 2023)]
[Notices]
[Pages 36588-36589]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11900]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1480]
Drug-Drug Interaction Assessment for Therapeutic Proteins;
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 final guidance for industry entitled ``Drug-Drug
Interaction Assessment for Therapeutic Proteins.'' With the continued
market growth and increased clinical use of therapeutic proteins, it is
important to understand the nature of and the potential for drug-drug
interactions (DDIs) with these products. The purpose of this guidance
is to help sponsors of investigational new drug applications (INDs) and
applicants of biologics license applications (BLAs) determine the need
for DDI studies for a therapeutic protein by providing a systematic,
risk-based approach. This guidance finalizes the draft guidance of the
same title issued on August 10, 2020.
DATES: The announcement of the guidance is published in the Federal
Register on June 5, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2020-D-1480 for ``Drug-Drug Interaction Assessment for Therapeutic
Proteins.'' 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 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: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162, Silver Spring, MD 20993, 301-796-
3473; or Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-8113.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Drug-Drug Interaction Assessment for Therapeutic Proteins.''
With the continued market growth and increased clinical use of
therapeutic proteins, it is important to understand the nature of and
the potential for DDIs with these products. This guidance supplements
the final FDA guidances for industry entitled ``In Vitro Drug
Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated
Drug Interactions'' and ``Clinical Drug Interaction Studies--Cytochrome
P450 Enzyme- and Transporter-Mediated Drug Interactions'' (January
2020) by providing recommendations for a systematic, risk-based
approach to determining the need for DDI studies for therapeutic
proteins. This guidance discusses considerations for assessing DDIs for
therapeutic proteins, including situations where determining the DDI
potential of a therapeutic protein is warranted. The guidance also
discusses various types of DDI assessments,
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considerations for study design, and recommendations for labeling.
This guidance finalizes the draft guidance entitled ``Drug-Drug
Interaction Assessment for Therapeutic Proteins'' issued on August 10,
2020 (85 FR 48259). FDA considered comments received on the draft
guidance as the guidance was finalized. Changes from the draft to the
final guidance include: (1) clarifying that FDA review divisions should
be consulted related to novel modalities, and that limitations exist in
knowledge related to effect of therapeutic proteins on transporters;
(2) including more literature references; (3) limiting the text related
to antibody-drug conjugates (ADCs) because a draft guidance on clinical
pharmacology considerations for ADCs has been published; and (4)
including language about potential use of various modeling approaches
on a case by case basis. In addition, editorial changes were made to
improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Drug-Drug Interaction Assessment for
Therapeutic Proteins.'' 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 for the submission of investigational new drug
applications in 21 CFR part 312 have been approved under OMB control
number 0910-0014. The collections of information for the submission of
new drug applications in 21 CFR part 314 have been approved under OMB
control number 0910-0001. The collections of information for the
submission of biologics license applications in 21 CFR part 601 have
been approved under OMB control 0910-0338. The collections of
information pertaining to the submission of prescription drug labeling
under 21 CFR 201.56 and 201.57 have been approved under OMB control
number 0910-0572.
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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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: May 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11900 Filed 6-2-23; 8:45 am]
BILLING CODE 4164-01-P
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