Notice2025-21692
FDA's Strategy Document on Innovative Manufacturing Technologies
Primary source
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Published
December 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Innovative Manufacturing Technologies (Strategy Document), which outlines specific actions FDA has taken and the Agency's plans for fiscal years 2023-2027 to facilitate the use of innovative manufacturing technologies. As part of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures Fiscal Years 2023-2027 (PDUFA VII), FDA committed to advance the use and implementation of innovative manufacturing. The actions described in the Strategy Document are based on lessons learned from FDA's experiences with submissions involving advanced manufacturing technologies as well as public input.
Full Text
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<title>Federal Register, Volume 90 Issue 228 (Monday, December 1, 2025)</title>
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[Federal Register Volume 90, Number 228 (Monday, December 1, 2025)]
[Notices]
[Pages 55133-55134]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21692]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2024-N-3945]
FDA's Strategy Document on Innovative Manufacturing Technologies
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 publication of FDA's Strategy Document on Innovative Manufacturing
Technologies (Strategy Document), which outlines specific actions FDA
has taken and the Agency's plans for fiscal years 2023-2027 to
facilitate the use of innovative manufacturing technologies. As part of
the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance
Goals and Procedures Fiscal Years 2023-2027 (PDUFA VII), FDA committed
to advance the use and implementation of innovative manufacturing. The
actions described in the Strategy Document are based on lessons learned
from FDA's experiences with submissions involving advanced
manufacturing technologies as well as public input.
DATES: The announcement of the strategy document is published in the
Federal Register on January 30, 2026.
ADDRESSES: You may submit either electronic or written comments 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
[[Page 55134]]
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-3945 for ``FDA's Strategy Document on Innovative
Manufacturing Technologies.'' 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.
<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 docket number, Date, or access the
information at: <a href="https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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: Elisa A. Nickum, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4226, Silver Spring, MD 20993, 301-796-
4226, <a href="/cdn-cgi/l/email-protection#682d04011b094626010b031d05280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="30755c5943511e7e59535b455d705654511e5858431e575f46">[email protected]</span></a>, or Phillip Kurs, Center for Biologics
Evaluation and Research, Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Innovative manufacturing technologies--including but not limited to
continuous manufacturing, distributed manufacturing, modern aseptic
manufacturing equipment and processes, and novel analytical methods--
can increase product development speed, bolster supply chains, improve
drug quality, and prevent drug shortages. On June 8, 2023, FDA
supported and participated in a public workshop hosted by the Duke-
Margolis Center for Health Policy on ``Advancing the Utilization and
Supporting the Implementation of Innovative Manufacturing Approaches.''
At this workshop, interested parties from industry shared feedback on
their interactions with the FDA's Center for Drug Evaluation and
Research (CDER) Emerging Technology Program (ETP) and Center for
Biologics Evaluation and Research (CBER) Advanced Technologies Team
(CATT) to guide submissions from persons or organizations using
innovative manufacturing technologies. Regulators, academic
researchers, and industry representatives discussed the current
barriers to using these technologies and shared ideas on how
initiatives such as the newly created Advanced Manufacturing
Technologies Designation Program (AMTDP) could alleviate these
barriers. The intent of this workshop was to fulfill a PDUFA VII
commitment related to advancing utilization and implementation of
innovative manufacturing, as well as section 506L(e)(1) of the Federal
Food, Drug, and Cosmetic Act, as amended by section 3213 of the Food
and Drug Omnibus Reform Act of 2022 regarding the AMTDP.
Based on lessons learned from the Agency's experience with
submissions involving advanced manufacturing, the topics discussed
during the June 8, 2023, workshop, and other public input, including
public comments received in response to the draft strategy document
announced in the Federal Register on September 12, 2024 (89 FR 74279),
FDA developed the Strategy Document. The Strategy Document outlines the
specific activities FDA has undertaken or intends to undertake to
facilitate the use of innovative manufacturing technologies, including:
continuing to enhance the ETP and CATT as a mechanism to support
innovation; implementing the AMTDP in a manner that incorporates
feedback on eligibility criteria; continuing to identify opportunities
for international harmonization of regulatory expectations in support
of further adoption of advanced manufacturing; supporting and utilizing
ongoing initiatives for advanced manufacturing to address potential
barriers; and supporting training in advanced manufacturing for FDA
regulatory staff.
The Strategy Document will be made available on the following FDA
web pages:
<bullet> CDER's Framework for Regulatory Advanced Manufacturing
Evaluation (FRAME) Initiative, available at: <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative</a>.
<bullet> CDER Emerging Technology Program (ETP), available at
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program-etp">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program-etp</a>.
<bullet> CBER Advanced Technologies Program, available at <a href="https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-program">https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-program</a>.
Authority: 21 U.S.C. 379g-h2. This document is being published to
fufill a commitment in the Prescription Drug User Fee Act (PDUFA)
Reauthorization Performance Goals and Procedures Fiscal Years 2023-2027
(PDUFA VII).
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21692 Filed 11-28-25; 8:45 am]
BILLING CODE 4164-01-P
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