Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Guidance for Industry; Availability, 63077-63079 [2022-22618]
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Federal Register / Vol. 87, No. 200 / Tuesday, October 18, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
announces a forthcoming public
advisory committee meeting of the
Blood Products Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues related to blood and products
derived from blood. At least one portion
of the meeting will be closed to the
public.
DATES: The meeting will be held
virtually on December 8, 2022, from
9:30 a.m. to 1:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The online web
conference meeting will be available at
the following link on the day of the
meeting: https://youtu.be/AQhF3AM_
ssg.
FOR FURTHER INFORMATION CONTACT:
Christina Vert or Tonica Burke, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993–0002,
240–402–8054, CBERBPAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before joining the meeting.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On December
8, 2022, the committee will meet in
open session to hear an overview of the
research programs of the Laboratory of
Emerging Pathogens and the Laboratory
of Molecular Virology, Division of
Emerging and Transfusion Transmitted
Diseases, Office of Blood Research and
Review, Center for Biologics Evaluation
and Research. After the open session,
the meeting will be closed to the public
for committee deliberations.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: On December 8, 2022,
from 9:30 a.m. to 12:35 p.m. Eastern
Time, the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
December 1, 2022. Oral presentations
from the public will be scheduled
between approximately 11:35 a.m. and
12:35 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before November 17, 2022. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 18, 2022.
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Closed Committee Deliberations: On
December 8, 2022, from 12:35 p.m. to
1:30 p.m. Eastern Time, the meeting will
be closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
recommendations of the advisory
committee regarding the progress of the
individual investigators’ research
programs, along with other information,
will be discussed during this session.
We believe that public discussion of
these recommendations on individual
scientists would constitute an
unwarranted invasion of personal
privacy.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Christina Vert
at CBERBPAC@fda.hhs.gov (see FOR
FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22612 Filed 10–17–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1298]
Acute Myeloid Leukemia: Developing
Drugs and Biological Products for
Treatment; Guidance for Industry;
Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Acute
Myeloid Leukemia: Developing Drugs
SUMMARY:
E:\FR\FM\18OCN1.SGM
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63078
Federal Register / Vol. 87, No. 200 / Tuesday, October 18, 2022 / Notices
and Biological Products for Treatment.’’
This guidance is intended to assist
sponsors in the clinical development of
drugs and biological products for the
treatment of acute myeloid leukemia
(AML). This guidance addresses FDA’s
current thinking regarding the overall
development program and clinical trial
designs for the development of drugs
and biological products to support an
indication of treatment of AML,
including indications limited to an
individual phase of treatment (for
example, maintenance, transplantation
preparative regimen, etc.). The guidance
addresses the topics of general drug
development, efficacy endpoints, and
exploratory and confirmatory trial
considerations for AML drug
development. In addition, the guidance
addresses investigational new drug
applications, new drug applications,
and biologics licensing applications for
AML drugs. This guidance finalizes the
draft guidance of the same title ‘‘Acute
Myeloid Leukemia: Developing Drugs
and Biological Products for Treatment’’
issued August 2020.
The announcement of the
guidance is published in the Federal
Register on October 18, 2022.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
khammond on DSKJM1Z7X2PROD with NOTICES
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’’).
VerDate Sep<11>2014
19:52 Oct 17, 2022
Jkt 259001
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–
2020–D–1298 for ‘‘Acute Myeloid
Leukemia: Developing Drugs and
Biological Products for Treatment.’’
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, 240–402–7500.
• 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
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.govinfo.gov/content/pkg/FR-201509-18/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://
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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, 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 or Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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:
Donna Przepiorka, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2116,
Silver Spring, MD 20993–0002, 301–
796–5358; Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Acute
Myeloid Leukemia: Developing Drugs
and Biological Products for Treatment.’’
This guidance is intended to assist
sponsors in the clinical development of
drugs and biological products for the
treatment of AML. This guidance
includes FDA’s current thinking
regarding the overall development
program and clinical trial designs to
support an indication of treatment of
AML, including indications limited to
an individual phase of treatment.
New classes of drugs are being
developed as alternatives to the
standard cytotoxic drugs for the
treatment of AML. The following factors
contribute substantially to the
complexity of clinical development
programs for such new drugs: the
expansion of treatment intent,
broadening of the intended population,
and development of a wide range of new
drug classes as alternatives to cytotoxic
E:\FR\FM\18OCN1.SGM
18OCN1
Federal Register / Vol. 87, No. 200 / Tuesday, October 18, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
drugs. This guidance includes FDA’s
thinking regarding general drug
development considerations, efficacy
endpoints, exploratory and confirmatory
trial considerations, and regulatory
submissions for AML drugs to facilitate
the development of new drugs for the
treatment of AML.
This guidance finalizes the draft
guidance entitled ‘‘Acute Myeloid
Leukemia: Developing Drugs and
Biological Products for Treatment’’
issued August 13, 2020 (85 FR 49383).
FDA considered comments received on
the draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include editorial
changes, clarifications of the time frame
for marrow sampling and peripheral
blood tests to establish complete
remission, the inclusion of markernegative patients in studies of targeted
therapies, and recommended operating
characteristics for safety-stopping rules.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Acute Myeloid
Leukemia: Developing Drugs and
Biological Products for Treatment.’’ 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 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 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; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; and
the collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents,
https://www.fda.gov/vaccines-bloodbiologics/guidance-compliance-
VerDate Sep<11>2014
19:52 Oct 17, 2022
Jkt 259001
regulatory-information-biologics/
biologics-guidances, or https://
www.regulations.gov.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22618 Filed 10–17–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0286]
Tissue Agnostic Drug Development in
Oncology; Draft Guidance for Industry;
Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Tissue
Agnostic Drug Development in
Oncology.’’ For the purpose of this
guidance, the term ‘‘tissue agnostic
oncology drug’’ refers to a drug that
targets a specific molecular alteration(s)
(a kind of biomarker) across multiple
cancer types as defined, for example by
organ, tissue, or tumor type. This draft
guidance describes the development of
tissue agnostic drugs, scientific
considerations in determining when
tissue agnostic oncology drug
development may be appropriate, and, if
appropriate, issues to be addressed
during such development. Tissue
agnostic drug development may
expedite or enable the development of
new therapies for patients with rare
cancer types.
DATES: Submit either electronic or
written comments on the draft guidance
by December 19, 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:
SUMMARY:
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
PO 00000
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63079
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–
2022–D–0286 for ‘‘Tissue Agnostic Drug
Development in Oncology.’’ 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, 240–402–7500.
• 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
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63077-63079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1298]
Acute Myeloid Leukemia: Developing Drugs and Biological Products
for Treatment; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Acute
Myeloid Leukemia: Developing Drugs
[[Page 63078]]
and Biological Products for Treatment.'' This guidance is intended to
assist sponsors in the clinical development of drugs and biological
products for the treatment of acute myeloid leukemia (AML). This
guidance addresses FDA's current thinking regarding the overall
development program and clinical trial designs for the development of
drugs and biological products to support an indication of treatment of
AML, including indications limited to an individual phase of treatment
(for example, maintenance, transplantation preparative regimen, etc.).
The guidance addresses the topics of general drug development, efficacy
endpoints, and exploratory and confirmatory trial considerations for
AML drug development. In addition, the guidance addresses
investigational new drug applications, new drug applications, and
biologics licensing applications for AML drugs. This guidance finalizes
the draft guidance of the same title ``Acute Myeloid Leukemia:
Developing Drugs and Biological Products for Treatment'' issued August
2020.
DATES: The announcement of the guidance is published in the Federal
Register on October 18, 2022.
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:
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-2020-D-1298 for ``Acute Myeloid Leukemia: Developing Drugs and
Biological Products for Treatment.'' 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, 240-402-7500.
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 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.govinfo.gov/content/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, 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 or Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Donna Przepiorka, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2116, Silver Spring, MD 20993-0002, 301-
796-5358; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological
Products for Treatment.'' This guidance is intended to assist sponsors
in the clinical development of drugs and biological products for the
treatment of AML. This guidance includes FDA's current thinking
regarding the overall development program and clinical trial designs to
support an indication of treatment of AML, including indications
limited to an individual phase of treatment.
New classes of drugs are being developed as alternatives to the
standard cytotoxic drugs for the treatment of AML. The following
factors contribute substantially to the complexity of clinical
development programs for such new drugs: the expansion of treatment
intent, broadening of the intended population, and development of a
wide range of new drug classes as alternatives to cytotoxic
[[Page 63079]]
drugs. This guidance includes FDA's thinking regarding general drug
development considerations, efficacy endpoints, exploratory and
confirmatory trial considerations, and regulatory submissions for AML
drugs to facilitate the development of new drugs for the treatment of
AML.
This guidance finalizes the draft guidance entitled ``Acute Myeloid
Leukemia: Developing Drugs and Biological Products for Treatment''
issued August 13, 2020 (85 FR 49383). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include editorial changes, clarifications
of the time frame for marrow sampling and peripheral blood tests to
establish complete remission, the inclusion of marker-negative patients
in studies of targeted therapies, and recommended operating
characteristics for safety-stopping rules.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Acute Myeloid Leukemia: Developing Drugs
and Biological Products for Treatment.'' 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 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 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; the collections
of information in 21 CFR part 601 have been approved under 0910-0338;
and the collections of information in 21 CFR 201.56 and 201.57 have
been approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or
https://www.regulations.gov.
Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22618 Filed 10-17-22; 8:45 am]
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