Notice2024-20891
New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments
Primary source
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Published
September 13, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is seeking public comments on the "New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation." The purpose is to seek public comments/feedback on the Integrated Review documentation generated by the Integrated Assessment of Marketing Applications for new drug products developed as part of the New Drugs Regulatory Program Modernization. The Agency hopes to receive public feedback on how this Integrated Review documentation can continue supporting our stakeholders' needs.
Full Text
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<title>Federal Register, Volume 89 Issue 178 (Friday, September 13, 2024)</title>
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[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74966-74968]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20891]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3878]
New Drugs Regulatory Program Modernization: Integrated Assessment
of Marketing Applications and Integrated Review Documentation; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
seeking public comments on the ``New Drugs Regulatory Program
Modernization: Integrated Assessment of Marketing Applications and
Integrated Review Documentation.'' The purpose is to seek public
comments/feedback on the Integrated Review documentation generated by
the Integrated Assessment of Marketing Applications for new drug
products developed as part of the New Drugs Regulatory Program
Modernization. The Agency hopes to receive public feedback on how this
Integrated Review documentation can continue supporting our
stakeholders' needs.
DATES: Submit either electronic or written comments on the notice by
December 12, 2024.
[[Page 74967]]
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. eastern time at the end of December 12, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
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-2024-N-3878 for ``New Drugs Regulatory Program Modernization:
Integrated Assessment of Marketing Applications and Integrated Review
Documentation; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Rhonda M. Hearns-Stewart, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6460, Silver Spring, MD 20993-0002, 240-
402-3180, <a href="/cdn-cgi/l/email-protection#36645e59585257187e53574458451b6542534157444276505257185e5e4518515940"><span class="__cf_email__" data-cfemail="beecd6d1d0dadf90f6dbdfccd0cd93edcadbc9dfcccafed8dadf90d6d6cd90d9d1c8">[email protected]</span></a>, with the subject line
``Collecting Public Feedback on the Integrated Review.''
SUPPLEMENTARY INFORMATION:
I. Background
The Integrated Assessment of Marketing Applications, which is part
of FDA's New Drugs Regulatory Program Modernization, includes a new
review template for the assessment and documentation of new drug
product marketing applications (e.g., new drug applications (NDAs) or
biologics license applications (BLAs)) in the Center for Drug
Evaluation and Research. The resultant Integrated Review is the product
of an interdisciplinary team assessment process that provides
collaborative discussions of key review issues that span multiple
disciplines and includes resolution of important issues pertinent to
benefit-risk assessments. This interdisciplinary approach facilitates
clarity of decision making and ensures input from relevant disciplines
in the consideration of scientific issues. FDA believes the format and
content of the Integrated Review documentation will provide sufficient
detail concerning the evidence of efficacy and assessment of risk and
risk management as well as a clearer description of FDA's analysis of
the scientific issues raised by the application and the scientific
reasoning supporting the benefit-risk determination. The overall
objective is to more effectively communicate the basis for FDA's
decision on applications.
This new Integrated Review document replaces the previous
documentation, which included a separate review document authored by
each discipline. It also replaces the multidisciplinary review (i.e.,
Unireview) in which each discipline provided a separate review section
but within a single review document. FDA implemented the Integrated
Review documentation for new molecular entities, original BLAs, and
select efficacy supplements. FDA plans to expand the scope to other
marketing application types in the near future.
The following guiding principles informed the Integrated Review
documentation:
<bullet> The importance of conducting an issue-focused assessment,
<bullet> Enhanced communication within the review team, and
<bullet> Strong interdisciplinary collaboration.
The Integrated Review documentation template has three main
components:
<bullet> Executive Summary:
[cir] Represents FDA's conclusions regarding key scientific and
regulatory issues while describing any differences of scientific
opinion or perspective,
[[Page 74968]]
[cir] Provides a summary of FDA's decision and assessment of the
application, including FDA's benefit-risk determination (as currently
employed in marketing application reviews), and
[cir] Provides an overall Agency assessment, including an overview
of the major decisions made during the review process, and a brief
discussion of the basis for the decisions.
<bullet> Interdisciplinary Assessment:
[cir] Includes succinct, integrated, focused analyses of the
evidence of benefit, risk and risk management, and therapeutic
individualization (e.g., special populations, drug interactions).
[cir] Highlights key review issues (including analyses specific to
key issues) the review team thinks are pertinent to the decision-making
process. Issues are presented and assessed in an interdisciplinary
manner.
[cir] Includes any dissenting data interpretations.
<bullet> Additional Analyses and Information:
[cir] Includes Discipline-Specific Appendices
[cir] Contains assessments and analyses that are supportive and/or
important to key facts/data or conclusions included in the overall
review and, in certain instances, may include discipline-specific
content (e.g., relevant pharmacology/toxicology information),
[cir] May contain work that did not directly impact the overall
assessment of benefit-risk, regulatory action, labeling, or risk-
mitigation plans, and
[cir] Includes separate reviews of reviewers who disagree with
significant elements of the Executive Summary and Interdisciplinary
Assessment sections or the decision of the Signatory Authority.
In general, the first two parts of the Integrated Review document
are expected to provide a complete explanation of FDA's action and
supporting analyses, with the third component (the additional analyses
and information) providing additional detail on the comprehensive
analyses FDA conducted in its review of the drug application. The
target audiences for this document are diverse and include those with a
specific interest in the application, such as the lay public, drug
sponsors, researchers, and others who are seeking to understand the
basis for FDA's decision.
II. Integrated Review Documentation
As part of FDA's ongoing evaluation of the Integrated Review
documentation, the Agency welcomes comments and any relevant
information specific to the Integrated Review that stakeholders wish to
share in a submission to the docket. However, we emphasize that the
focus is to seek input that prioritizes feedback specifically on
characteristics of the Integrated Review document. Please see
information and examples relevant to the Integrated Review at <a href="https://www.fda.gov/drugs/news-events-human-drugs/new-drugs-regulatory-program-modernization-integrated-assessment-marketing-applications-and">https://www.fda.gov/drugs/news-events-human-drugs/new-drugs-regulatory-program-modernization-integrated-assessment-marketing-applications-and</a>.
Furthermore, we anticipate that the most informative suggestions
would not be specific to an indication, a therapeutic area, or a
disease but rather apply across multiple indications, therapeutic
areas, or diseases. The Agency is interested in receiving responses to
the following questions/topics, in addition to any general comments the
public might have. For convenience, it would be helpful if commenters
refer to the numbered question and topic when submitting responses and
comments.
1. We are interested in preserving for stakeholders what they find
most useful in FDA reviews.
a. Comparing the Integrated Review to previous review
documentation, is there any information you are having difficulty
locating?
b. Are you able to use the Integrated Review for the same purpose
that you used previous reviews? If not, please provide specific
examples.
2. We are interested in specific recommendations about any areas of
the Integrated Review documentation of the Integrated Assessment that
can be improved to meet the needs of stakeholders.
3. We are interested in stakeholders' views regarding the
advantages and disadvantages of an interdisciplinary assessment
presentation of key review issues and the resultant integration of the
assessments of multiple disciplines into a single Integrated Review
document.
4. We would like to know whether the new format of the Integrated
Review documentation for the Integrated Assessment provides clarity of
benefit-risk assessments and informs your knowledge of FDA's basis for
making decisions.
5. Based on the integrated review, were the issues that concerned
the review team clear and understandable? If so, what helped achieve
this? If not, what can be improved?
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20891 Filed 9-12-24; 8:45 am]
BILLING CODE 4164-01-P
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