Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information, 71374-71376 [2024-19712]
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71374
Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
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cobas SARS-Co V~2 & Influenza AIB nucleic acid test for use on the cobas Liat System, that
includes the cobas SARS~Co y;;2 & Influenza A/B QualityControl Kit; that is the. EUA labeled
product and that was distributed prior to revocation of the EUA, when such product.is used in
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test for. use on the cobas Liat System pro.duct for which FDA had issued an EUA and the product
fotwhich FDA has cleared under 510(k) are 1nanufacturedw1derthe same quality system with
the same lot release criteria;. Roche Molecular Systems, Inc. should instruct customers who have
remaining cobas SARS-Co W2 & Influenza AJBNucleic.acid testfor use on the cobas Liat
System EUA labeled product inventory that they may use theirEUA product in combination
with the package insert/manufacturer instructions for Use labeling associated with the 510(k.)
clearance issued on July 27, 2023. Roche Moleculai' Systems, Inc. should also instruct
customers who have remaining cdbas SARS-CoV-2& InfluenzaA/B QualityControl KitEllA
product inventory that they may use their EUA product in combination.with the package
insert/manufacturer instructions for use labeling associated. with the 5l0(k.) clearance on Jilly 27,
2023 and. that the cobas SARS-Co V-2 & Influenza A/B Quality Co11trol Kit EUA labeled
product inventory may also be used in combination with the C◊bas SARSsCoV~2 & Influenza
A/B nucleic acid test for use on. the cobas Liat System product, which FDA has cleared under
510(k), FDA encourages Roche Molecular Systems; Inc., to use all appropriate means,(e.g,, mail,
email, or website link.)fo.notify affected customers ofthis EUArevocation and provide accessto
the packageinsert/manufa:cturer instructions for use labeling associated with the 510(k)
cleara.nce on July 27, 2023,
Notice ofthis revocation will be published in the Federal Register., pursuant to section 564(h)(l)
of the Act.
Sincerely,
!Js/l
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19724 Filed 8–30–24; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3904]
tkelley on LAP7H3WLY3PROD with NOTICES2
Identifying Priority Focus Areas for
Future Guidance Development and
Engagement With Interested Parties in
Model-Informed Drug Development;
Request for Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for Information.
The Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER) within the Food and
SUMMARY:
VerDate Sep<11>2014
22:46 Aug 30, 2024
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Frm 00125
Fmt 4703
Sfmt 4703
Drug Administration (FDA or Agency)
are announcing a request for
information (RFI) for advancing modelinformed drug development (MIDD).
The purpose of this request is to obtain
feedback on how to increase application
of established MIDD approaches in
regulatory decision making, to identify
how emerging MIDD approaches are
being incorporated within drug product
development, and to identify
opportunities to enhance interactions
with FDA when discussing MIDD
approaches. We intend to use the
information submitted in response to
this request to identify and prioritize
potential focus areas for future policy or
guidance development and enhance
engagement with interested parties,
including interactions as part of the
U:\REGISTER\03SEN1.SGM
03SEN1
EN03SE24.086</GPH>
Jeffrey E. Shuren, M.D,, J;D,
Director
Centerfot DevicesandRadiologfoaI Health
Food and t>rugAdrninistration
Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
MIDD Paired Meeting Program and
other formal meetings with drug
developers.
Either electronic or written
comments on the notice must be
submitted by November 4, 2024.
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
November 4, 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.
DATES:
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’’).
tkelley on LAP7H3WLY3PROD with NOTICES2
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–
VerDate Sep<11>2014
22:46 Aug 30, 2024
Jkt 262001
2024–N–3904 for ‘‘Identifying Priority
Focus Areas for Future Guidance
Development and Engagement with
Interested Parties in Model-Informed
Drug Development; Request for
Information.’’ 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-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:
Yvonne Knight, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2142,
Silver Spring, MD 20993, 301–796–
2133, Yvonne.Knight@fda.hhs.gov, with
PO 00000
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Fmt 4703
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71375
the subject line ‘‘MIDD Meetings
Program for CDER’’; or Christopher
Egelebo, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 5340, Silver Spring,
MD 20993, 240–402–8625,
Christopher.Egelebo@fda.hhs.gov, with
the subject line ‘‘MIDD Meetings
Program for CBER.’’
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a request for
information entitled ‘‘Identifying
Priority Focus Areas for Future
Guidance Development and Engagement
with Interested Parties in ModelInformed Drug Development.’’
Information submitted in response to
this notice will be used by CDER,
including by its Quantitative Medicine
Center of Excellence, and CBER to assist
in identifying and prioritizing potential
focus areas for future policy or guidance
development and engagement with
interested parties.
MIDD approaches integrate exposurebased biological and statistical models
derived from nonclinical and clinical
data sources in drug development and
decision making. MIDD applications
span the life cycle of new drug product
development. MIDD approaches use a
variety of quantitative methods (e.g.,
population pharmacokinetic (popPK)
modeling, exposure-response (E–R)
modeling, physiologically based
pharmacokinetic (PBPK) modeling,
systems pharmacology/mechanistic
modeling, disease progression
modeling, drug-trial-disease modeling
and simulation, artificial intelligence/
machine learning (AI/ML) approaches)
to help assess the risks and benefits of
drug products, contribute to the
evidentiary framework for efficacy and/
or safety, and optimize dosing regimens
for patients, among other applications.
When successfully applied, MIDD
approaches might reduce animal testing,
improve clinical trial design and
efficiency, inform identification of
dosing regimens with improved benefitrisk profiles, increase the probability of
regulatory success through synergetic
engagement with interested parties, and
optimize drug dosing/therapeutic
individualization in the absence of
dedicated trials.
Beginning with Prescription Drug
User Fee Act (PDUFA) VI, FDA began
granting focused meetings as part of the
MIDD Paired Meeting Pilot to: (1)
provide a forum for regulatory
interaction between drug developers
and FDA on the application of MIDD
approaches in specific drug
development programs; and (2) provide
U:\REGISTER\03SEN1.SGM
03SEN1
71376
Federal Register / Vol. 89, No. 170 / Tuesday, September 3, 2024 / Notices
an opportunity for FDA to provide
advice regarding how particular MIDD
approaches can be used in a specific
drug development program. Other
deliverables as part of PDUFA VI
included increasing regulatory science
and review capacity in MIDD
approaches and convening multiple
workshops to identify best practices for
MIDD (topics including E–R, PBPK,
disease progression modeling, and
immunogenicity assessments). In
addition, FDA published or revised
multiple guidances on MIDD. As part of
PDUFA VII, the MIDD Paired Meeting
Program has been continued and this
RFI is to elicit public input on future
focus areas for advancing MIDD. More
information on the MIDD Paired
Meeting program can be found at
https://www.fda.gov/drugs/
development-resources/modelinformed-drug-development-pairedmeeting-program.
tkelley on LAP7H3WLY3PROD with NOTICES2
II. Request for Information
FDA is interested in detailed
comments on the topics listed in this
section below to identify and inform
future priorities for MIDD-related
policy, including guidance development
and engagement with interested parties.
The topics identified in this section are
not meant to be exhaustive. FDA is also
interested in any other pertinent
information that interested parties
would like to share related to guidance
and enhancing MIDD-related
interactions with FDA. FDA encourages
interested parties to provide the specific
rationale and basis for their comments,
including any available supporting data
and information.
A. Methods and Best Practices
Several quantitative approaches, such
as popPK, E–R, and PBPK, are routinely
employed in drug development and
regulatory assessment. The Agency aims
to identify areas within these
approaches that would benefit from the
development of additional policies or
guidance on methodology and best
practices. In addition, with this RFI, the
Agency is seeking input to explore
potential guidance needs and
appropriately identify and prioritize
potential topics for guidance
development in all emerging MIDD
approaches for drug and biological
products, including but not limited to,
AI/ML used in both drug design and
evaluation and digital-twin technology.
extrinsic factors), drug properties,
placebo effects, nonclinical and clinical
E–R relationships—are potent tools and
can be utilized across all stages of the
drug development life cycle to support
decision making. This is particularly
important for rare diseases and
emerging therapeutic and prophylactic/
preventative modalities where there
may be practical and ethical challenges
in conducting traditional drug
development programs or where there is
limited drug development experience.
We seek input on the need to develop
guidances that discuss considerations to
facilitate MIDD methods development,
application, uptake, and acceptance in
specific therapeutic areas. Related
topics include identification of
opportunities for incorporation of realworld data, specific therapeutic
modality considerations, and preclinical
to clinical translations and to
appropriately identify and prioritize
potential topics in this area.
C. Regulatory Engagement
Building on the success of the MIDD
Paired Meeting Program, FDA is
interested in better understanding ways
to facilitate discussion around MIDD
approaches outside the MIDD Paired
Meeting Program as part of regulatory
meetings and regulatory submissions.
This includes identifying what is
currently working well and what are the
barriers (e.g., technical, regulatory)
encountered while trying to interact
with FDA on MIDD-related activities.
D. Communication of Policies and
Interested Parties’ Engagement
FDA continues to engage on MIDD
approaches as part of external
workshops with interested parties,
including workshops described and
completed under PDUFA VI. FDA seeks
to identify and prioritize potential
topics and better ways for
communication and engagement with
interested parties.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19712 Filed 8–30–24; 8:45 am]
BILLING CODE 4164–01–P
B. Context-Specific Considerations
MIDD approaches that leverage
comprehensive information—including
disease and patient population
characteristics (e.g., intrinsic and
VerDate Sep<11>2014
22:46 Aug 30, 2024
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Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In accordance with the
Federal Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that the
charter for the Advisory Committee on
Organ Transplantation (ACOT or
Committee) is renewed. The effective
date of the renewed charter is August
31, 2024.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Shelley Tims Grant, Division of
Transplantation, HRSA, 5600 Fishers
Lane, 08W67, Rockville, Maryland
20857; 301–443–8036; or sgrant@
hrsa.gov.
ACOT
provides advice and recommendations
to the Secretary of Health and Human
Services on policy, program
development, and other matters of
significance concerning the activities
under 42 U.S.C. 217a; Section 222 of the
Public Health Service Act, as amended.
ACOT provides advice and
recommendations on proposed or
implemented Organ Procurement and
Transplantation Network policies
(including those related to organ
donation, procurement, allocation,
transplantation, patient safety, and data
collection, among other policy topics),
and on such other matters that the
Secretary of Health and Human Services
determines. ACOT ensures checks and
balances, transparency, and a focus on
patient-centered practices. The topics
covered by ACOT may be broad and
cross-sectional.
The renewed charter for ACOT was
approved on August 9, 2024. The filing
date is August 31, 2024. Renewal of the
ACOT charter gives authorization for
the Committee to operate until August
31, 2026.
A copy of the ACOT charter is
available on the ACOT website at
https://www.hrsa.gov/advisorycommittees/organ-transplantation. A
copy of the charter also can be obtained
by accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
SUPPLEMENTARY INFORMATION:
U:\REGISTER\03SEN1.SGM
03SEN1
]]>Agencies
[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71374-71376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19712]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3904]
Identifying Priority Focus Areas for Future Guidance Development
and Engagement With Interested Parties in Model-Informed Drug
Development; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for Information.
-----------------------------------------------------------------------
SUMMARY: The Center for Drug Evaluation and Research (CDER) and Center
for Biologics Evaluation and Research (CBER) within the Food and Drug
Administration (FDA or Agency) are announcing a request for information
(RFI) for advancing model-informed drug development (MIDD). The purpose
of this request is to obtain feedback on how to increase application of
established MIDD approaches in regulatory decision making, to identify
how emerging MIDD approaches are being incorporated within drug product
development, and to identify opportunities to enhance interactions with
FDA when discussing MIDD approaches. We intend to use the information
submitted in response to this request to identify and prioritize
potential focus areas for future policy or guidance development and
enhance engagement with interested parties, including interactions as
part of the
[[Page 71375]]
MIDD Paired Meeting Program and other formal meetings with drug
developers.
DATES: Either electronic or written comments on the notice must be
submitted by November 4, 2024.
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 November 4, 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-3904 for ``Identifying Priority Focus Areas for Future
Guidance Development and Engagement with Interested Parties in Model-
Informed Drug Development; Request for Information.'' 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: Yvonne Knight, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2142, Silver Spring, MD 20993, 301-796-
2133, [email protected], with the subject line ``MIDD Meetings
Program for CDER''; or Christopher Egelebo, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 5340, Silver Spring, MD 20993, 240-402-
8625, [email protected], with the subject line ``MIDD
Meetings Program for CBER.''
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a request for information entitled ``Identifying
Priority Focus Areas for Future Guidance Development and Engagement
with Interested Parties in Model-Informed Drug Development.''
Information submitted in response to this notice will be used by CDER,
including by its Quantitative Medicine Center of Excellence, and CBER
to assist in identifying and prioritizing potential focus areas for
future policy or guidance development and engagement with interested
parties.
MIDD approaches integrate exposure-based biological and statistical
models derived from nonclinical and clinical data sources in drug
development and decision making. MIDD applications span the life cycle
of new drug product development. MIDD approaches use a variety of
quantitative methods (e.g., population pharmacokinetic (popPK)
modeling, exposure-response (E-R) modeling, physiologically based
pharmacokinetic (PBPK) modeling, systems pharmacology/mechanistic
modeling, disease progression modeling, drug-trial-disease modeling and
simulation, artificial intelligence/machine learning (AI/ML)
approaches) to help assess the risks and benefits of drug products,
contribute to the evidentiary framework for efficacy and/or safety, and
optimize dosing regimens for patients, among other applications. When
successfully applied, MIDD approaches might reduce animal testing,
improve clinical trial design and efficiency, inform identification of
dosing regimens with improved benefit-risk profiles, increase the
probability of regulatory success through synergetic engagement with
interested parties, and optimize drug dosing/therapeutic
individualization in the absence of dedicated trials.
Beginning with Prescription Drug User Fee Act (PDUFA) VI, FDA began
granting focused meetings as part of the MIDD Paired Meeting Pilot to:
(1) provide a forum for regulatory interaction between drug developers
and FDA on the application of MIDD approaches in specific drug
development programs; and (2) provide
[[Page 71376]]
an opportunity for FDA to provide advice regarding how particular MIDD
approaches can be used in a specific drug development program. Other
deliverables as part of PDUFA VI included increasing regulatory science
and review capacity in MIDD approaches and convening multiple workshops
to identify best practices for MIDD (topics including E-R, PBPK,
disease progression modeling, and immunogenicity assessments). In
addition, FDA published or revised multiple guidances on MIDD. As part
of PDUFA VII, the MIDD Paired Meeting Program has been continued and
this RFI is to elicit public input on future focus areas for advancing
MIDD. More information on the MIDD Paired Meeting program can be found
at https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program.
II. Request for Information
FDA is interested in detailed comments on the topics listed in this
section below to identify and inform future priorities for MIDD-related
policy, including guidance development and engagement with interested
parties. The topics identified in this section are not meant to be
exhaustive. FDA is also interested in any other pertinent information
that interested parties would like to share related to guidance and
enhancing MIDD-related interactions with FDA. FDA encourages interested
parties to provide the specific rationale and basis for their comments,
including any available supporting data and information.
A. Methods and Best Practices
Several quantitative approaches, such as popPK, E-R, and PBPK, are
routinely employed in drug development and regulatory assessment. The
Agency aims to identify areas within these approaches that would
benefit from the development of additional policies or guidance on
methodology and best practices. In addition, with this RFI, the Agency
is seeking input to explore potential guidance needs and appropriately
identify and prioritize potential topics for guidance development in
all emerging MIDD approaches for drug and biological products,
including but not limited to, AI/ML used in both drug design and
evaluation and digital-twin technology.
B. Context-Specific Considerations
MIDD approaches that leverage comprehensive information--including
disease and patient population characteristics (e.g., intrinsic and
extrinsic factors), drug properties, placebo effects, nonclinical and
clinical E-R relationships--are potent tools and can be utilized across
all stages of the drug development life cycle to support decision
making. This is particularly important for rare diseases and emerging
therapeutic and prophylactic/preventative modalities where there may be
practical and ethical challenges in conducting traditional drug
development programs or where there is limited drug development
experience. We seek input on the need to develop guidances that discuss
considerations to facilitate MIDD methods development, application,
uptake, and acceptance in specific therapeutic areas. Related topics
include identification of opportunities for incorporation of real-world
data, specific therapeutic modality considerations, and preclinical to
clinical translations and to appropriately identify and prioritize
potential topics in this area.
C. Regulatory Engagement
Building on the success of the MIDD Paired Meeting Program, FDA is
interested in better understanding ways to facilitate discussion around
MIDD approaches outside the MIDD Paired Meeting Program as part of
regulatory meetings and regulatory submissions. This includes
identifying what is currently working well and what are the barriers
(e.g., technical, regulatory) encountered while trying to interact with
FDA on MIDD-related activities.
D. Communication of Policies and Interested Parties' Engagement
FDA continues to engage on MIDD approaches as part of external
workshops with interested parties, including workshops described and
completed under PDUFA VI. FDA seeks to identify and prioritize
potential topics and better ways for communication and engagement with
interested parties.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19712 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-P
