New Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request for Comments, 74966-74968 [2024-20891]
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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices
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• Confidential Submissions—To
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and other applicable disclosure law. For
more information about FDA’s posting
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FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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:
Candace Nalls, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, 301–636–0510,
Candace.Nalls@fda.hhs.gov, or FDA
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Therefore, you should always check the
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default.htm and scroll down to the
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appropriate advisory committee meeting
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SUPPLEMENTARY INFORMATION: Agenda:
On November 7, 2024, the Committee
will discuss, make recommendations,
and vote on clinical information related
to a De Novo request for the ProSense
Cryoablation System sponsored by
IceCure Medical Ltd. The discussion
will focus on the sponsor’s proposed
indication: ‘‘for use in the treatment of
patients with early stage, low-risk breast
cancer for the treatment of breast cancer
with adjuvant endocrine therapy.’’
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material will be available at the location
of the advisory committee meeting and
at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before October 17,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled on November
7, 2024, between approximately 1:45
p.m. and 2:45 p.m. eastern time. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
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evidence or arguments they wish to
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allotted for each presentation may be
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requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
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public hearing session. The contact
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regarding their request to speak by
October 15, 2024. Persons attending
FDA’s advisory committee meetings are
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advised that FDA is not responsible for
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For press inquiries, please contact the
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FDA welcomes the attendance of the
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.).
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20889 Filed 9–12–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
E:\FR\FM\13SEN1.SGM
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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov 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.
ADDRESSES:
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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 https://www.regulations.gov.
• 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:
• 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.
• 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
VerDate Sep<11>2014
17:53 Sep 12, 2024
Jkt 262001
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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
https://www.regulations.gov. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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, Rhonda.Hearns-Stewart@
fda.hhs.gov, with the subject line
‘‘Collecting Public Feedback on the
Integrated Review.’’
SUPPLEMENTARY INFORMATION:
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74967
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:
• The importance of conducting an
issue-focused assessment,
• Enhanced communication within
the review team, and
• Strong interdisciplinary
collaboration.
The Integrated Review documentation
template has three main components:
• Executive Summary:
Æ Represents FDA’s conclusions
regarding key scientific and
regulatory issues while describing
any differences of scientific opinion
or perspective,
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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices
Æ 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
Æ 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.
• Interdisciplinary Assessment:
Æ Includes succinct, integrated,
focused analyses of the evidence of
benefit, risk and risk management,
and therapeutic individualization
(e.g., special populations, drug
interactions).
Æ 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.
Æ Includes any dissenting data
interpretations.
• Additional Analyses and Information:
Æ Includes Discipline-Specific
Appendices
Æ 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),
Æ May contain work that did not
directly impact the overall
assessment of benefit-risk,
regulatory action, labeling, or riskmitigation plans, and
Æ 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.
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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
https://www.fda.gov/drugs/news-eventshuman-drugs/new-drugs-regulatoryprogram-modernization-integratedassessment-marketing-applications-and.
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 benefitrisk 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?
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2803]
Sandoz Inc., et al.; Withdrawal of
Approval of 20 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on June 21, 2024. The
document announced the withdrawal of
approval of 20 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of July 22,
2024. The document indicated that FDA
was withdrawing approval of the ANDA
076648 for nitrofurantoin
(monohydrate/macrocrystals) capsules,
75 milligrams (mg) and 25 mg, held by
Aurobindo Pharma USA Inc., 279
Princeton-Hightstown Rd., East
Windsor, NJ 08520; and the ANDA
090723 for duloxetine hydrochloride
capsules, delayed-release pellets,
Equivalent to (EQ) 20 mg base, EQ 30
mg base, and EQ 60 mg base, held by
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., 150 Motor
Pkwy., Suite 401, 4th Floor, Rm. 430,
Hauppauge, NY 11788. Before FDA
withdrew the approval of these ANDAs,
Aurobindo Pharma USA Inc., and
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., informed FDA
that they did not want the approval of
the ANDAs withdrawn. Because
Aurobindo Pharma USA Inc. and
Marksans Pharma, Inc., U.S. Agent for
Marksans Pharma Ltd., timely requested
that approval of their respective ANDAs
not be withdrawn, the approvals are still
in effect. This notice corrects these
errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 301–
796–3471, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, June 21,
2024 (89 FR 52057), appearing on page
E:\FR\FM\13SEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74966-74968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20891]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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 https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected], 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:
The importance of conducting an issue-focused assessment,
Enhanced communication within the review team, and
Strong interdisciplinary collaboration.
The Integrated Review documentation template has three main
components:
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.
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.
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 https://www.fda.gov/drugs/news-events-human-drugs/new-drugs-regulatory-program-modernization-integrated-assessment-marketing-applications-and.
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
