Notice2025-11323
Post-Warning Letter Meetings Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
Primary source
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Published
June 20, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Post- Warning Letter Meetings Under GDUFA." This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA), as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter). Specifically, this guidance describes the process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility's ongoing remediation efforts to address current good manufacturing practice (CGMP) deficiencies described in a warning letter, how to prepare and submit a complete meeting package, and how FDA intends to conduct the Post-Warning Letter Meeting.
Full Text
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<title>Federal Register, Volume 90 Issue 117 (Friday, June 20, 2025)</title>
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[Federal Register Volume 90, Number 117 (Friday, June 20, 2025)]
[Notices]
[Pages 26309-26311]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11323]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-3370]
Post-Warning Letter Meetings Under Generic Drug User Fee
Amendments; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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[[Page 26310]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Post-
Warning Letter Meetings Under GDUFA.'' This guidance provides
information on the implementation of the Post-Warning Letter Meeting
process for certain drug manufacturing facilities, a program
enhancement agreed upon by the Agency and industry as part of the
negotiations relating to the reauthorization of the Generic Drug User
Fee Amendments (GDUFA), as described in ``GDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027''
(GDUFA III commitment letter). Specifically, this guidance describes
the process detailed in the GDUFA III commitment letter for how an
eligible facility may request a Post-Warning Letter Meeting with FDA
regarding the facility's ongoing remediation efforts to address current
good manufacturing practice (CGMP) deficiencies described in a warning
letter, how to prepare and submit a complete meeting package, and how
FDA intends to conduct the Post-Warning Letter Meeting.
DATES: The announcement of the guidance is published in the Federal
Register on June 20, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 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-2023-D-3370 for ``Post-Warning Letter Meetings Under GDUFA.''
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, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Rebecca Frey-Cooper, Office of
Manufacturing Quality, Center for Drug Evaluation and Research (HFD-
003), Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 240-402-4127, <a href="/cdn-cgi/l/email-protection#74261116111717155a3206110d59371b1b041106341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="adffc8cfc8cececc83ebdfc8d480eec2c2ddc8dfedcbc9cc83c5c5de83cac2db">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Post-Warning Letter Meetings Under GDUFA.'' This guidance
provides information on the implementation of the Post-Warning Letter
Meeting process, a program enhancement agreed upon by the Agency and
industry as part of the negotiations relating to the reauthorization of
GDUFA, as described in the GDUFA III commitment letter. Specifically,
this guidance describes the process in the GDUFA III commitment letter
for how an eligible facility may request a Post-Warning Letter Meeting
with FDA regarding the facility's ongoing remediation efforts to
address CGMP deficiencies described in a warning letter, how to prepare
and submit a complete meeting package, and how FDA intends to conduct
the Post-Warning Letter Meeting.
This guidance finalizes the draft guidance entitled ``Post-Warning
Letter Meetings Under GDUFA'' issued on September 5, 2023 (88 FR
60686). FDA considered comments received on the draft guidance as the
guidance was finalized. Though no significant changes were made, the
final guidance includes editorial changes made for clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current
[[Page 26311]]
thinking of FDA on ``Post-Warning Letter Meetings Under GDUFA.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
FDA considered the applicability of Executive Order 14192, per
Office of Management and Budget (OMB) guidance in M-25-20, and finds
this action to be deregulatory in nature.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001. The collections of
information in 21 CFR parts 210 and 211 pertaining to CGMP has been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 11 for electronic records and electronic
signatures have been approved under OMB control number 0910-0303. The
collections of information pertaining to the submissions of GDUFA III
commitment letter, meetings related to generic drug development, and
the Generic Drug User Fee Program have been approved under OMB control
number 0910-0727.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 13, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11323 Filed 6-18-25; 8:45 am]
BILLING CODE 4164-01-P
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