Notice2022-10030
Benefit-Risk Considerations for Product Quality Assessments; Draft Guidance for Industry; Availability
Primary source
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Published
May 10, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Benefit- Risk Considerations for Product Quality Assessments." This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to such applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment. This guidance discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA's understanding of the potential effect on a product. This guidance also discusses how unresolved product quality issues may be addressed in the context of regulatory decision making. The guidance notes that product quality assessments are also done for abbreviated new drug applications (ANDAs), and it discusses how, in certain rare circumstances, unresolved product quality issues may be addressed when there is an urgent clinical need for an ANDA (e.g., a public health emergency or a pervasive drug shortage).
Full Text
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<title>Federal Register, Volume 87 Issue 90 (Tuesday, May 10, 2022)</title>
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[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28016-28018]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10030]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0168]
Benefit-Risk Considerations for Product Quality Assessments;
Draft Guidance for Industry; Availability
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 availability of a draft guidance for industry entitled ``Benefit-
Risk Considerations for Product Quality Assessments.'' This guidance
describes the benefit-risk principles applied by FDA when conducting
product quality-related assessments of chemistry, manufacturing, and
controls (CMC) information submitted for FDA assessment as part of
original new drug applications (NDAs), original biologics license
applications (BLAs), or supplements to such applications, in addition
to other information (e.g., inspectional findings) available to FDA
during its assessment. This guidance discusses how FDA assesses risks,
sources of uncertainty, and possible mitigation strategies for a
product quality-related issue and how those considerations inform FDA's
understanding of the potential effect on a product. This guidance also
discusses how unresolved product quality issues may be addressed in the
context of regulatory decision making. The guidance notes that product
quality assessments are also done for abbreviated new drug applications
(ANDAs), and it discusses how, in certain rare circumstances,
unresolved product quality issues may be addressed when there is an
urgent clinical need for
[[Page 28017]]
an ANDA (e.g., a public health emergency or a pervasive drug shortage).
DATES: Submit either electronic or written comments on the draft
guidance by July 11, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2022-D-0168 for ``Benefit-Risk Considerations for Product Quality
Assessments.'' 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 the draft 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Natalia Comella, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Benefit-Risk Considerations for Product Quality
Assessments.'' This guidance describes the benefit-risk principles
applied by FDA when conducting product quality-related assessments of
CMC information submitted for FDA assessment as part of original NDAs
under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), original BLAs under section 351 of the Public Health
Service Act (42 U.S.C. 262), or supplements to such applications, in
addition to other information (e.g., inspectional findings) available
to FDA during its assessment. This guidance discusses how FDA assesses
risks, sources of uncertainty, and possible mitigation strategies for a
product quality-related issue and how those considerations inform FDA's
understanding of the potential effect on a product. The outcome of the
product quality assessment results in a determination as to whether an
applicant has developed a drug product, manufacturing process, and
control strategy that will consistently result in a product of
acceptable quality when manufactured at the facilities named in the
application.
When a regulatory decision regarding the approval of an NDA or BLA
is made, FDA considers the overall benefit(s) and risks identified for
the product. This can include any residual risk related to unresolved
product quality issues if they directly affect the assessment. This
guidance also discusses how unresolved product quality issues may be
addressed in the context of regulatory decision making. The guidance
notes that product quality assessments are also done for ANDAs, and it
discusses how, in certain rare circumstances, unresolved product
quality issues may be addressed when there is an urgent clinical need
for an ANDA (e.g., a public health emergency or a pervasive drug
shortage).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Benefit-Risk
Considerations for Product Quality Assessments.'' 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
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it satisfies the requirements of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR parts 601 and 610 have been
approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft 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: May 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10030 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P
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