Notice2025-15797
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability
Primary source
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Published
August 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development." This guidance is intended to assist sponsors in identifying an optimized dosage for radiopharmaceutical therapies (RPT) for oncology indications during clinical development and prior to submitting a marketing application for a new indication and usage. The guidance provides considerations for RPT dosage optimization in RPT development programs.
Full Text
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<title>Federal Register, Volume 90 Issue 158 (Tuesday, August 19, 2025)</title>
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[Federal Register Volume 90, Number 158 (Tuesday, August 19, 2025)]
[Notices]
[Pages 40370-40371]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15797]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-1757]
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization
During Clinical Development; Draft Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During
Clinical Development.'' This guidance is intended to assist sponsors in
identifying an optimized dosage for radiopharmaceutical therapies (RPT)
for oncology indications during clinical development and prior to
submitting a marketing application for a new indication and usage. The
guidance provides considerations for RPT dosage optimization in RPT
development programs.
DATES: Submit either electronic or written comments on the draft
guidance by October 20, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
[[Page 40371]]
<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-2025-D-1757 for ``Oncology Therapeutic Radiopharmaceuticals: Dosage
Optimization During Clinical Development.'' 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: Oncology Center of Excellence, Food
and Drug Administration, <a href="/cdn-cgi/l/email-protection#511e12147c16243835303f323422113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="440b07016903312d20252a272137042220256a2c2c376a232b32">[email protected]</span></a>; or William Maguire,
Center for Drug Evaluation and Research, Food and Drug Administration,
240-402-7225.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Oncology Therapeutic Radiopharmaceuticals: Dosage
Optimization During Clinical Development.'' This guidance is intended
to assist sponsors in identifying an optimized dosage for RPT for
oncology indications during clinical development and prior to
submitting a marketing application for a new indication and usage.
Dosages of RPT have typically been limited to normal organ absorbed
dose limits derived from external beam radiotherapy (EBRT) data.
However, differences in physical properties and treatment delivery
between RPT and EBRT lessen the applicability of these organ absorbed
dose limits to RPT. In addition, RPT have the potential to cause
delayed, cumulative, and/or irreversible toxicity that is not captured
in traditional dose-finding trials. This guidance provides
considerations for RPT dosage optimization in RPT development programs,
including safeguards to mitigate the risk of unacceptable long-term
toxicity from RPT dosages that exceed EBRT limits or previously
characterized RPT dosages. The recommendations should be considered
along with the FDA guidance entitled ``Optimizing the Dosage of Human
Prescription Drugs and Biological Products for the treatment of
Oncologic Diseases'' (August 2024).
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 ``Oncology
Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical
Development.'' 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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 Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in in 21 CFR part 312 have been approved under OMB control number 0910-
0014 and the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001.
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: August 14, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15797 Filed 8-18-25; 8:45 am]
BILLING CODE 4164-01-P
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