Notice2026-19277
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
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Published
September 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing year five of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to assist with CMC readiness for products regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that have accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.
Full Text
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<title>Federal Register, Volume 91 Issue 181 (Monday, September 21, 2026)</title>
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[Federal Register Volume 91, Number 181 (Monday, September 21, 2026)]
[Notices]
[Pages 59783-59785]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2396]
Chemistry, Manufacturing, and Controls Development and Readiness
Pilot Program; Program Announcement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
year five of the Chemistry, Manufacturing, and Controls (CMC)
Development and Readiness Pilot (CDRP). This program facilitates the
expedited CMC development of products under an investigational new drug
application (IND) based on the anticipated clinical benefit of earlier
patient access to the products. FDA has implemented this pilot program
to assist with CMC readiness for products regulated by both the Center
for Biologics Evaluation and Research (CBER) and the Center for Drug
Evaluation and Research (CDER) that have accelerated clinical
development timelines. To accelerate CMC development and facilitate CMC
readiness, the pilot features increased communication between FDA and
sponsors and explores the use of science- and risk-based regulatory
approaches, as applicable. This notice outlines the eligibility
criteria and process for submitting a request to participate in the
pilot.
DATES: Starting October 1, 2026, FDA will accept requests to
participate in year five of the CDRP program. See the ``Participation''
section of this document for eligibility criteria, instructions on how
to submit a request to participate, and selection criteria and process.
FOR FURTHER INFORMATION CONTACT: Tanya Clayton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20993-0002, 301-
796-0871; or Phillip Kurs, Center for Biologics Evaluation and
Research, Food and Drug Administration, 240-402-7911.
For general questions about the CDRP Program for CBER:
<a href="/cdn-cgi/l/email-protection#563f3832232522242f78343f393a39313f352516303237783e3e2578313920"><span class="__cf_email__" data-cfemail="0a63646e7f797e78732468636566656d6369794a6c6e6b24626279246d657c">[email protected]</span></a>.
For general questions about the CDRP Program for CDER: <a href="/cdn-cgi/l/email-protection#b5d6d1d0c798dac5c498dac5c7da98d6c7d4d198dcdbc4c0dcc7dcd0c6f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="dcbfb8b9aef1b3acadf1b3acaeb3f1bfaebdb8f1b5b2ada9b5aeb5b9af9cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Development programs for CBER- and CDER-regulated drugs and
biologics intended to diagnose, treat, or prevent a serious disease or
condition where there is an unmet medical need may have accelerated
clinical development timelines. Yet, marketing applications for
products in expedited development programs still need to meet FDA's
approval standards, including manufacturing facility compliance with
current good manufacturing practice (CGMP). Products with accelerated
clinical development activities may face challenges in expediting CMC
development activities to align with the accelerated clinical
timelines. Successfully expediting CMC readiness may require additional
interactions with FDA during product development and, if applicable,
warrant the use of science- and risk-based regulatory approaches to
streamline CMC development activities so that clinical benefits of
earlier patient access to these products can be realized.
As described in the FDA Prescription Drug User Fee Act (PDUFA) VII
Commitment Letter for fiscal years (FYs) 2023 Through 2027 (Ref. 1),
FDA implemented the CDRP program to facilitate CMC readiness for
selected CBER- and CDER-regulated products with accelerated clinical
development timelines in FY 2023. To accelerate CMC development and
facilitate CMC readiness, the pilot features increased communication
between FDA and sponsors and explores the use of science- and risk-
based regulatory approaches, such as those described in the FDA
guidance for industry titled ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (May 2014) (Ref. 2), as applicable.
FDA (CBER and CDER) is continuing to administer the CDRP throughout
the PDUFA VII program to facilitate the CMC development of selected
products under INDs which have expedited clinical development
timeframes, based on the anticipated clinical benefits of earlier
patient access to the products. For sponsors participating in the
pilot, FDA will provide product-specific CMC advice during product
development, including two additional CMC-focused Type B meetings, as
well as additional CMC-focused discussions. To support these
interactions, once a sponsor is admitted to the pilot, FDA will expand
the IND quality assessment team so as to ensure it has representation
from the full complement of relevant disciplines. The increased
communication between FDA review staff and sponsors is intended to
ensure a mutual understanding of approaches to completing CMC
activities, including what information should be provided at the
appropriate timepoint (i.e., at the time of new drug application (NDA)
or biologics license application (BLA) submission, prior to the end of
the review cycle, or post-approval) to ensure CMC readiness for a
marketing application.
To promote innovation and understanding in this area, FDA held a
public workshop on September 10, 2025, and issued a strategy document
on July 23, 2026, focused on CMC aspects of expedited development
incorporating lessons from the CDRP (Ref. 3). The public workshop
explored the benefits and challenges of expedited CMC development.
During the workshop, FDA participants described the aims of, and
experience with, the CDRP. Participating sponsors and industry experts
discussed their experience with
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the CDRP and opportunities for its improvement. FDA then issued the
strategy document based on the experience and learnings from the CDRP
and workshop, as well as on the experience from other submissions for
products with accelerated clinical development timelines.
II. Participation
FDA will accept requests to participate in the CDRP program
continuously throughout the fiscal year. FDA will select no more than
nine proposals per fiscal year, with approximately two-thirds being
CBER-regulated products and one-third CDER-regulated products. FDA will
renew the CDRP program each fiscal year and announce the opening of the
pilot program in the Federal Register for the remainder of this PDUFA
VII period (until the end of FY 2027). However, once enrolled in the
pilot a participating firm will continue to be enrolled in the program
until their marketing application is filed. Sponsors who are interested
in participating in the pilot program should submit a request to
participate in the pilot as an amendment to their IND. The cover letter
should state ``Request To Participate in the CMC Development and
Readiness Pilot.''
A. Eligibility Criteria
The following eligibility criteria apply for consideration for
participation in the pilot program:
1. Joint CBER and CDER Eligibility Criteria
<bullet> An active commercial IND (see the definition of commercial
IND at <a href="https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/research-investigational-new-drug-applications-what-you-need-know">https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/research-investigational-new-drug-applications-what-you-need-know</a>).
<bullet> IND has been submitted in, or converted to, Electronic
Common Technical Document (eCTD) format, unless the IND is of a type
granted a waiver from eCTD format as per FDA's guidance for industry
titled ``Providing Regulatory Submissions in Electronic Format--Certain
Human Pharmaceutical Product Applications and Related Submissions Using
the eCTD Specifications'' (September 2024) (Ref. 4).
<bullet> INDs for combination products (21 CFR 3.2(e)) are
eligible; products that require significant cross-Center interactions
(e.g., complex combination products) may be less likely to be selected
for the pilot.
<bullet> In general, there should be enough time remaining before
submission of the marketing application to allow the pilot to have an
impact on CMC readiness.
<bullet> CMC-related information is provided to demonstrate a
commitment to pursue a CMC development plan that aligns with the
expedited clinical development program (see ``CMC Development Plan'' in
section II.B of this document for details).
<bullet> Due to the differences in product complexity between CBER-
and CDER-regulated products, the following eligibility and selection
criteria differ between the Centers.
2. CBER-Specific Eligibility Criteria
<bullet> IND is an existing, CBER-regulated IND intended for
submission as an application for licensure of a biological product
under section 351(a) of the Public Health Service Act (PHS Act) (42
U.S.C. 262(a)) for cellular therapies, gene therapies, and other
products regulated by the Office of Therapeutic Products/CBER or
vaccines regulated by the Office of Vaccines Research and Review/CBER.
<bullet> IND has a Breakthrough Therapy (BT) or Regenerative
Medicine Advance Therapy (RMAT) designation.
3. CDER-Specific Eligibility Criteria
<bullet> IND is an existing, CDER-regulated IND for a product
intended for submission as an application for: (1) approval of a new
drug submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)), or (2) licensure of a biological
product under section 351(a) of the PHS Act.
<bullet> IND has an expedited clinical timeframe warranted based on
anticipated clinical benefits of earlier patient access. This would
include INDs with BT or Fast Track designations as well as other INDs
that meet this criterion, with eligibility to be determined by FDA.
B. What To Submit in a Request To Participate in the Pilot
To participate in the CDRP, sponsors should submit a written
request as an amendment to the IND. In addition to providing a point of
contact and noting any expedited program designations the IND has
received to date, the request should include the following information.
CMC Development Plan
To focus pilot resources where they will be most useful and have an
impact on the timeliness with which CMC readiness is achieved,
prospective applicants to the pilot program should include in their
Request to Participate a brief description of their CMC development
plan, with a prospective timeline for CMC development that would align
with when the clinical development program is expected to be complete:
<bullet> The plan should list the remaining CMC tasks and
activities anticipated to be necessary, with estimated timeframes. This
part of the plan should cover the following CMC-related areas:
[cir] Currently available product characterization and preliminary
identification of critical quality attributes.
[cir] Summary of the current drug substance and drug product
manufacturing process and control strategy (including assays, noting
any that are still under development).
[cir] A brief description of the proposed commercial scale
manufacturing and control strategy, including any necessary microbial
control strategy--focusing on important differences from clinical
scale.
[cir] Identification of potential commercial manufacturing
facilities, including any contract facilities, or, at least, the type
(in house, contract manufacturing organization) of facilities
anticipated.
[cir] Plans for ensuring product availability at approval.
[cir] Drug substance and drug product stability assessment plan.
[cir] Strategy for process validation (see FDA's guidance for
industry titled ``Process Validation: General Principles and
Practices'' (January 2011) (Ref. 5)).
<bullet> Given the expedited clinical timeframe, mapping out a plan
for manufacturing readiness within the same overall timespan may reveal
potential challenges in accomplishing CMC readiness. The plan should
highlight any anticipated CMC challenges--whether related to the
bullets above or otherwise. This will facilitate FDA engagement and
collaboration. Participants in the pilot should plan to discuss these
challenges with FDA during the pilot. For CDER-regulated products, see
MAPP 5015.13, ``Quality Assessment for Products in Expedited Programs''
(July 2025) (Ref. 6).
<bullet> The CMC Development Plan should include proposed timing
(i.e., month and year) for the first CMC-specific Type B meeting
afforded by the pilot.
C. Selection Criteria and Process
FDA intends to select CBER and CDER INDs based on the criteria
outlined below. Requests will be acknowledged and reviewed when
received. FDA intends to issue a Proceed to Disclosure Agreement
letter,
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if selected into the pilot, or deny letter within 90 days of receipt.
In selecting INDs for the pilot program, FDA intends to consider
factors such as: (1) anticipated clinical benefits of facilitating
earlier patient access to the product, (2) novelty of the product, (3)
complexity of the product or its manufacturing process, including
technology, and (4) anticipated CMC challenges. Overall, FDA intends to
seek balance and diversity in product types and therapeutic indications
to obtain a variety of relevant experience and learnings from the
pilot.
D. FDA-Sponsor Interactions During the Pilot
During this CDRP program, sponsors will have the ability to discuss
their product development strategies and goals with FDA review staff
during the two dedicated Type B meetings, as well as in additional CMC-
focused discussions. Besides additional interactions and collaboration
with FDA, for those INDs in the pilot, FDA will assemble a team to
support the CMC development and readiness of the IND, e.g.,
participating in the meetings and other discussions under the pilot.
In preparation for a meeting, sponsors should submit written
questions along with a background information package clearly marked as
a ``PDUFA VII CDRP meeting'' as part of the cover letter to enable FDA
review staff to address the questions. The briefing package should be
submitted to the corresponding IND. Meetings associated with the pilot
should be requested by sponsors. For additional information on meetings
and other communications between the sponsors and FDA, see the FDA
guidance for industry titled ``Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products'' (August 2026) (Ref. 7), CDER
MAPP 6025.6: ``Good Review Practice: Management of Breakthrough
Therapy-Designated Drugs and Biologics'' (Rev. 1) (February 2024) (Ref.
8), CBER ``SOPP 8101.1: Regulatory Meetings with Sponsors and
Applicants for Drugs and Biological Products'' (December 2025) (Ref.
9), and CBER ``SOPP 8212: Breakthrough Therapy Products--Designation
and Management'' (April 2026) (Ref. 10).
III. Paperwork Reduction Act of 1995
Collections of information from fewer than 10 respondents within
any 12-month period are not subject to the Paperwork Reduction Act of
1995 (PRA) (5 CFR 1320.3(c)(4)). To the extent this information
collection involves 10 or more respondents within any 12-month period,
the collections of information are subject to the PRA. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The
collections of information for NDAs, formal meetings with sponsors and
applicants for PDUFA products, and the PDUFA VII Commitment Letter have
been approved under OMB control number 0910-0001. The collections of
information for INDs have been approved under OMB control number 0910-
0014. The collections of information for BLAs have been approved under
OMB control number 0910-0338. The collections of information pertaining
to CGMP requirements have been approved under OMB control number 0910-
0139. The collections of information pertaining to expedited programs
for serious conditions for drugs and biologics and breakthrough
therapy-designation for drugs and biologics have been approved under
OMB control number 0910-0765.
IV. References
The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240-402-7500, and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Although FDA verified the website addresses in this document, please
note that websites are subject to change over time.
1. ``PDUFA Reauthorization Performance Goals and Procedures Fiscal
Years 2023 Through 2027.'' Available at <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
2. FDA, Guidance for Industry: ``Expedited Programs for Serious
Conditions--Drugs and Biologics'' (May 2014). Available at <a href="https://www.fda.gov/media/86377/download">https://www.fda.gov/media/86377/download</a>.
3. FDA's Strategy Document on Facilitating Chemistry, Manufacturing,
and Controls Readiness for Products with Accelerated Clinical
Development (July 2026). Available at <a href="https://www.fda.gov/media/193747/download?attachment">https://www.fda.gov/media/193747/download?attachment</a>.
4. FDA, Guidance for Industry: ``Providing Regulatory Submissions in
Electronic Format--Certain Human Pharmaceutical Product Applications
and Related Submissions Using the eCTD Specifications'' (Rev. 8)
(September 2024). Available at <a href="https://www.fda.gov/media/135373/download">https://www.fda.gov/media/135373/download</a>.
5. FDA, Guidance for Industry: ``Process Validation: General
Principles and Practices'' (Rev. 1) (January 2011): <a href="https://www.fda.gov/media/71021/download">https://www.fda.gov/media/71021/download</a>.
6. CDER MAPP 5015.13: ``Quality Assessment for Products in Expedited
Programs'' (Rev. 1) (July 2025). Available at <a href="https://www.fda.gov/media/187958/download?attachment">https://www.fda.gov/media/187958/download?attachment</a>.
7. FDA, Guidance for Industry: ``Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA Products'' (August 2026): <a href="https://www.fda.gov/media/172311/download">https://www.fda.gov/media/172311/download</a>.
8. CDER MAPP 6025.6: ``Good Review Practice: Management of
Breakthrough Therapy-Designated Drugs and Biologics'' (Rev. 1)
(February 2024). Available at <a href="https://www.fda.gov/media/89155/download">https://www.fda.gov/media/89155/download</a>.
9. CBER ``SOPP 8101.1: ``Regulatory Meetings with Sponsors and
Applicants for Drugs and Biological Products'' (December 2025).
Available at <a href="https://www.fda.gov/media/84040/download?attachment">https://www.fda.gov/media/84040/download?attachment</a>.
10. CBER ``SOPP 8212: Breakthrough Therapy Products--Designation and
Management'' (April 2026). Available at <a href="https://www.fda.gov/media/98351/download?attachment">https://www.fda.gov/media/98351/download?attachment</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19277 Filed 9-18-26; 8:45 am]
BILLING CODE 4164-01-P
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