Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability, 60215-60217 [2023-18841]
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Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
have not established a safe level for a
residue from the extralabel use of any
new animal drug and, therefore, have
not required the development of
analytical methodology, we believe that
there may be instances when analytical
methodology will be required. We are,
therefore, estimating the reporting
burden based on two methods being
required annually. The requirement to
establish an analytical method may be
fulfilled by any interested person. We
believe that the sponsor of the drug will
be willing to develop the method in
most cases. Alternatively, FDA, the
sponsor, and perhaps a third party may
60215
cooperatively arrange for method
development. The respondents may be
sponsors of new animal drugs, State, or
Federal and/or State Agencies,
academia, or individuals.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Part; activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
530.22(b); Submission(s) of analytical method ...................
2
1
2
4,160
8,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
support of a regulatory decision
regarding the effectiveness or safety of a
drug that are not subject to the IND
regulations. This guidance finalizes the
draft guidance of the same title issued
on December 9, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on August 31, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2021–D–1214]
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’’).
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–18834 Filed 8–30–23; 8:45 am]
BILLING CODE 4164–01–P
Considerations for the Use of RealWorld Data and Real-World Evidence
To Support Regulatory DecisionMaking for Drug and Biological
Products; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Considerations for the Use of RealWorld Data and Real-World Evidence to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ FDA is
issuing this guidance as part of its RealWorld Evidence (RWE) Program for
drugs and to satisfy, in part, the
mandate under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) to issue
guidance about the use of RWE in
regulatory decision making. This
guidance discusses the applicability of
FDA’s investigational new drug
application (IND) regulations to various
clinical study designs that utilize realworld data (RWD) and clarifies the
Agency’s expectations regarding clinical
studies using RWD submitted to FDA in
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:04 Aug 30, 2023
Jkt 259001
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
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Fmt 4703
Sfmt 4703
• 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–
2021–D–1214 for ‘‘Considerations for
the Use of Real-World Data and RealWorld Evidence to Support Regulatory
Decision-Making for Drug and
Biological Products.’’ 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
E:\FR\FM\31AUN1.SGM
31AUN1
60216
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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://
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 to the 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:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3226,
Silver Spring, MD 20993–0002, 301–
796–3161, Dianne.Paraoan@
fda.hhs.gov; or Anne Taylor, 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, Anne.Taylor@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Considerations for the Use of RealWorld Data and Real-World Evidence to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ The
VerDate Sep<11>2014
18:04 Aug 30, 2023
Jkt 259001
guidance discusses the following major
topics: (1) applicability of 21 CFR part
312 to studies using RWD and (2)
regulatory considerations for noninterventional (observational) studies
involving the use of RWD. Regulatory
considerations addressed by the
guidance include the following: (1)
transparency for data collection and
analysis, (2) access to RWD, (3) study
monitoring, (4) safety reporting, (5)
other sponsor responsibilities, and (6)
the analysis of RWD generated from the
use of a product under an emergency
use authorization (EUA) in routine
practice.
Section 3022 of the 21st Century
Cures Act (Cures Act) of 2016 amended
the FD&C Act to add section 505F,
Utilizing Real World Evidence (21
U.S.C. 355g), which requires FDA to
issue guidance about the use of RWE in
regulatory decision-making. In addition,
under the Prescription Drug User Fee
Amendments of 2017 (PDUFA VI), FDA
is committed to publish draft guidance
on how RWE can contribute to the
assessment of safety and effectiveness in
regulatory submissions. In 2018, FDA
created an RWE Framework and an
RWE Program to evaluate the potential
use of RWE to help support the approval
of a new indication for a drug already
approved under the FD&C Act or to help
support or satisfy postapproval study
requirements. In late 2021, FDA utilized
the RWE Program to issue draft
guidances outlining considerations for
the use of RWD and RWE in regulatory
decision making to satisfy the Cures Act
mandate and the PDUFA VI
commitment.
This guidance finalizes the draft
guidance of the same title issued on
December 9, 2021 (86 FR 70131). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include transfer of
relevant definitions from the glossary to
the text as well as additional language
about data generated in clinical practice
for products used under an EUA
consistent with a mandate under the
Food and Drug Omnibus Reform Act of
2022. Clarifying information was also
added, including the use of existing
regulatory pathways for third parties to
provide patient-level data to FDA when
a sponsor cannot submit such data to
FDA through traditional channels. In
addition, editorial changes were made
to improve clarity.
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 ‘‘Considerations for
the Use of Real-World Data and Real-
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
World Evidence to Support Regulatory
Decision-Making for Drug 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 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 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 21 CFR part 11
pertaining to electronic records and
signatures have been approved under
OMB control number 0910–0303. The
collections of information in 21 CFR
parts 50 and 56 relating to protection of
human subjects and Institutional
Review Boards have been approved
under OMB control number 0910–0130.
The collections of information in 21
CFR part 310 relating to postmarketing
adverse drug experience reporting have
been approved under OMB control
number 0910–0230. The collections of
information in 21 CFR part 600 for
general records and postmarketing
adverse experience reporting pertaining
to biological products have been
approved under OMB control number
0910–0308. The collections of
information in 21 CFR parts 310, 314,
and 600 pertaining to adverse event and
product experience reporting have been
approved under OMB control number
0910–0291. 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. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information in 21 CFR part 600 have
been approved under OMB control
number 0910–0458.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at: https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 88, No. 168 / Thursday, August 31, 2023 / Notices
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2023–18841 Filed 8–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2024]
Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act.’’ This
guidance clarifies the enhanced drug
distribution security requirements listed
in the Federal Food, Drug, and Cosmetic
Act (FD&C Act). In addition, this
guidance outlines and makes
recommendations on the system
attributes necessary to enable secure
tracing of product at the package level,
including allowing for the use of
verification, inference, and aggregation,
as necessary. This guidance finalizes the
draft guidance of the same title issued
on June 4, 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on August 31, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ddrumheller on DSK120RN23PROD with NOTICES1
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
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
VerDate Sep<11>2014
18:04 Aug 30, 2023
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–2024 for ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act.’’ 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
60217
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://
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 to the 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:
Abha Kundi, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3130, drugtrackandtrace@
fda.hhs.gov; or Anne Taylor, 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
‘‘Enhanced Drug Distribution Security at
the Package Level Under the Drug
Supply Chain Security Act.’’ The Drug
Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113–54) was signed
into law on November 27, 2013.
The DSCSA outlines critical steps to
achieve electronic pharmaceutical
supply chain interoperability by
November 27, 2023, that will enhance
E:\FR\FM\31AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60215-60217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18841]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1214]
Considerations for the Use of Real-World Data and Real-World
Evidence To Support Regulatory Decision-Making for Drug and Biological
Products; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, 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
``Considerations for the Use of Real-World Data and Real-World Evidence
to Support Regulatory Decision-Making for Drug and Biological
Products.'' FDA is issuing this guidance as part of its Real-World
Evidence (RWE) Program for drugs and to satisfy, in part, the mandate
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue
guidance about the use of RWE in regulatory decision making. This
guidance discusses the applicability of FDA's investigational new drug
application (IND) regulations to various clinical study designs that
utilize real-world data (RWD) and clarifies the Agency's expectations
regarding clinical studies using RWD submitted to FDA in support of a
regulatory decision regarding the effectiveness or safety of a drug
that are not subject to the IND regulations. This guidance finalizes
the draft guidance of the same title issued on December 9, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on August 31, 2023.
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-2021-D-1214 for ``Considerations for the Use of Real-World Data and
Real-World Evidence to Support Regulatory Decision-Making for Drug and
Biological Products.'' 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
[[Page 60216]]
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 to the 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: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3226, Silver Spring, MD 20993-0002, 301-
796-3161, [email protected]; or Anne Taylor, 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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Considerations for the Use of Real-World Data and Real-World
Evidence to Support Regulatory Decision-Making for Drug and Biological
Products.'' The guidance discusses the following major topics: (1)
applicability of 21 CFR part 312 to studies using RWD and (2)
regulatory considerations for non-interventional (observational)
studies involving the use of RWD. Regulatory considerations addressed
by the guidance include the following: (1) transparency for data
collection and analysis, (2) access to RWD, (3) study monitoring, (4)
safety reporting, (5) other sponsor responsibilities, and (6) the
analysis of RWD generated from the use of a product under an emergency
use authorization (EUA) in routine practice.
Section 3022 of the 21st Century Cures Act (Cures Act) of 2016
amended the FD&C Act to add section 505F, Utilizing Real World Evidence
(21 U.S.C. 355g), which requires FDA to issue guidance about the use of
RWE in regulatory decision-making. In addition, under the Prescription
Drug User Fee Amendments of 2017 (PDUFA VI), FDA is committed to
publish draft guidance on how RWE can contribute to the assessment of
safety and effectiveness in regulatory submissions. In 2018, FDA
created an RWE Framework and an RWE Program to evaluate the potential
use of RWE to help support the approval of a new indication for a drug
already approved under the FD&C Act or to help support or satisfy
postapproval study requirements. In late 2021, FDA utilized the RWE
Program to issue draft guidances outlining considerations for the use
of RWD and RWE in regulatory decision making to satisfy the Cures Act
mandate and the PDUFA VI commitment.
This guidance finalizes the draft guidance of the same title issued
on December 9, 2021 (86 FR 70131). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include transfer of relevant definitions
from the glossary to the text as well as additional language about data
generated in clinical practice for products used under an EUA
consistent with a mandate under the Food and Drug Omnibus Reform Act of
2022. Clarifying information was also added, including the use of
existing regulatory pathways for third parties to provide patient-level
data to FDA when a sponsor cannot submit such data to FDA through
traditional channels. In addition, editorial changes were made to
improve clarity.
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 ``Considerations for the Use of Real-World
Data and Real-World Evidence to Support Regulatory Decision-Making for
Drug 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 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
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
21 CFR part 11 pertaining to electronic records and signatures have
been approved under OMB control number 0910-0303. The collections of
information in 21 CFR parts 50 and 56 relating to protection of human
subjects and Institutional Review Boards have been approved under OMB
control number 0910-0130. The collections of information in 21 CFR part
310 relating to postmarketing adverse drug experience reporting have
been approved under OMB control number 0910-0230. The collections of
information in 21 CFR part 600 for general records and postmarketing
adverse experience reporting pertaining to biological products have
been approved under OMB control number 0910-0308. The collections of
information in 21 CFR parts 310, 314, and 600 pertaining to adverse
event and product experience reporting have been approved under OMB
control number 0910-0291. 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. The collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR part 600 have been approved under
OMB control number 0910-0458.
III. Electronic Access
Persons with access to the internet may obtain the guidance at:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
[[Page 60217]]
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18841 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P
