Notice2023-11321
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability
Primary source
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Published
May 26, 2023
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products." This draft guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 and type 2 diabetes mellitus. In this draft guidance, antidiabetic drug refers to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management.
Full Text
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<title>Federal Register, Volume 88 Issue 102 (Friday, May 26, 2023)</title>
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34164-34166]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11321]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0625]
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials
Investigating Antidiabetic Drugs and Biological Products; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Diabetes
Mellitus: Efficacy Endpoints for Clinical Trials Investigating
Antidiabetic Drugs and Biological Products.'' This draft guidance is
intended to help sponsors develop antidiabetic drugs for adults and
children with type 1 and type 2 diabetes mellitus. In this draft
guidance, antidiabetic drug refers to drugs intended to improve
glycemic control, including drugs intended to reduce diabetes-related
hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to
mitigate iatrogenic hypoglycemia associated with diabetes management.
DATES: Submit either electronic or written comments on the draft
guidance by August 24, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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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-2023-D-0625 for ``Diabetes Mellitus: Efficacy Endpoints for
Clinical Trials Investigating Antidiabetic Drugs and Biological
Products.'' 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: Debra Reid, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4221, Silver Spring, MD 20993, 240-402-9143.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Diabetes Mellitus: Efficacy Endpoints for Clinical Trials
Investigating Antidiabetic Drugs and Biological Products.'' In this
draft guidance we discuss approaches to demonstrating efficacy of
antidiabetic drugs for adults and children with type 1 and type 2
diabetes mellitus. This draft guidance provides recommendations for
demonstrating efficacy for drugs that are intended to reduce diabetes-
related hyperglycemia (i.e., antihyperglycemic drugs) and to mitigate
iatrogenic hypoglycemia associated with diabetes management. The use of
hemoglobin A1c as a primary endpoint for glycemic-control trials is
discussed along with recommendations for trial design and conduct to
allow for adequate data interpretation. The draft guidance also
provides hypoglycemia definitions, trial design considerations for
hypoglycemia efficacy endpoints, and hypoglycemia measurement methods.
Additional efficacy endpoints are also briefly considered.
This draft guidance replaces, in part, the draft guidance for
industry ``Diabetes Mellitus: Developing Drugs and Therapeutic
Biologics for Treatment and Prevention'' (73 FR 11420) published in
February 2008 and withdrawn in 2020. In March 2020, FDA withdrew the
February 2008 draft guidance because its recommendations for safety
assessment were outdated. At the same time, FDA issued the draft
guidance for industry ``Type 2 Diabetes Mellitus: Evaluating the Safety
of New Drugs for Improving Glycemic Control'' March 10, 2020 (85 FR
13903) (available at <a href="https://www.fda.gov/media/135936/download">https://www.fda.gov/media/135936/download</a>). This
draft guidance, when finalized, will provide FDA's current
recommendations on this issue.
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 ``Diabetes
Mellitus: Efficacy Endpoints for Clinical Trials Investigating
Antidiabetic Drugs and Biological Products.'' 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.
II. Paperwork Reduction Act of 1995
While this draft 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 draft guidance. The previously approved
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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.
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 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11321 Filed 5-25-23; 8:45 am]
BILLING CODE 4164-01-P
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