83 FR 30752 - Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.'' The purpose of this draft guidance is to assist sponsors in designing appropriate nonclinical studies before initiation of first-in-human (FIH) trials and through product approval. In addition, this draft guidance provides recommendations for product labeling, such as duration of contraception to minimize potential risk to a developing embryo/fetus and recommendations for lactating women to minimize potential risk to a nursing infant. This draft guidance intends to provide recommendations for nonclinical programs in a unique and challenging area of product development, provide a more consistent approach in nonclinical studies and product labeling, and reduce the conduct of nonclinical studies that are not informative for product use.

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30752-30753]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1772]


Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies 
and Labeling Recommendations; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Oncology 
Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling 
Recommendations.'' The purpose of this draft guidance is to assist 
sponsors in designing appropriate nonclinical studies before initiation 
of first-in-human (FIH) trials and through product approval. In 
addition, this draft guidance provides recommendations for product 
labeling, such as duration of contraception to minimize potential risk 
to a developing embryo/fetus and recommendations for lactating women to 
minimize potential risk to a nursing infant. This draft guidance 
intends to provide recommendations for nonclinical programs in a unique 
and challenging area of product development, provide a more consistent 
approach in nonclinical studies and product labeling, and reduce the 
conduct of nonclinical studies that are not informative for product 
use.

DATES: Submit either electronic or written comments on the draft 
guidance by August 28, 2018 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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-2018-D-1772 for ``Oncology Therapeutic Radiopharmaceuticals: 
Nonclinical Studies and Labeling Recommendations; Draft Guidance for 
Industry; Availability.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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 https://www.regulations.gov. 
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

[[Page 30753]]

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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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.
    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: Haleh Saber, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2117, Silver Spring, MD 20993-0002, 301-
796-7550, or John Leighton, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
2204, Silver Spring, MD 20993-0002, 301-796-7550.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Oncology Therapeutic Radiopharmaceuticals: Nonclinical 
Studies and Labeling Recommendations.'' This draft guidance presents 
FDA's current thinking on nonclinical studies needed to support FIH 
studies and for approval for therapeutic radiopharmaceuticals. In this 
draft guidance, the term therapeutic radiopharmaceutical refers to a 
pharmaceutical that contains a radionuclide and is used in patients 
with cancer for the treatment or for palliation of tumor-related 
symptoms (e.g., pain). This draft guidance discusses the following 
concepts: (1) Evaluation of toxicities from the ligand; (2) evaluation 
of radiation toxicities; and (3) information for product labeling as 
related to reproductive toxicity, genotoxicity, carcinogenicity, 
contraception, and use in lactating women.
    Currently, no FDA or International Council for Harmonisation 
guidance addresses nonclinical studies supporting FIH trials and 
approval for radiopharmaceuticals for treatment of cancer. The guidance 
for industry entitled ``Nonclinical Evaluation of Late Radiation 
Toxicity of Therapeutic Radiopharmaceuticals'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079242.pdf) describes nonclinical studies to address late 
radiation toxicity only. This draft guidance provides further 
clarification of recommendations made in that guidance for the timing 
and design of late radiation toxicity studies. This draft guidance 
intends to bring consistency in nonclinical safety assessment and in 
product labeling for therapeutic radiopharmaceuticals and to reduce the 
number of nonclinical studies that are not informative for product use.
    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 nonclinical 
studies and labeling recommendations for oncology therapeutic 
radiopharmaceuticals. 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in 21 CFR 312.23(a)(8) for submitting 
pharmacological and toxicology information has been approved under OMB 
control number 0910-0014; the collection of information in 21 CFR 
201.56 and 201.57 for preparing human prescription drug labeling has 
been approved under OMB control number 0910-0572; and the collection of 
information in the ``Content and Format of Labeling for Human 
Prescription Drug and Biological Products; Requirements for Pregnancy 
and Lactation Labeling'' final rule has been approved under OMB control 
number 0910-0624.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14055 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P