Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability, 20207-20209 [2024-05969]
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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substance prior to bottling and
distribution to create the street drug.
Marshall and his DTO also obtained
counterfeited commercial-grade
pharmaceutical labels designed to look
exactly like the genuine labels for the
prescription cough syrup from another
supplier.
In his role with Woodfield, Mr. Reed
knew that the Marshall DTO was adding
active ingredients to the syrup
Woodfield sold to the Marshall DTO.
From approximately April 2015 until
January 2019, Mr. Reed was principally
responsible for the large-scale
production of syrup base for the
Marshall DTO. Beginning on or about
May 26, 2015, Mr. Reed became the
Marshall DTO’s principal source of
supply for promethazine. Mr. Reed
brokered the promethazine from a lab
chemical supplier based in New York
that delivered the promethazine directly
to the Marshall DTO. In January 2019
Mr. Reed was fired from his position at
Woodfield.
As a result of this conviction, FDA
sent Mr. Reed, by certified mail, on
January 5, 2024, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(a)(2)(B), that Mr. Reed was
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act. The
proposal informed Mr. Reed of the
proposed debarment and offered him an
opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Reed received the proposal and notice
of opportunity for a hearing on January
11, 2024. Mr. Reed failed to request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Willis
Reed has been convicted of a felony
under Federal law for conduct relating
to the regulation of a drug product
under the FD&C Act.
As a result of the foregoing finding,
Mr. Reed is permanently debarred from
VerDate Sep<11>2014
16:53 Mar 20, 2024
Jkt 262001
providing services in any capacity to a
person with an approved or pending
drug product application, effective (see
DATES) (see sections 306(a)(2)(B) and
306(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses in any capacity the services of Mr.
Reed during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Reed provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment, he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Mr. Reed during
his period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act (21 U.S.C.
335a(c)(1)(B))). Note that, for purposes
of sections 306 and 307 of the FD&C
Act, a ‘‘drug product’’ is defined as a
drug subject to regulation under section
505, 512, or 802 of this FD&C Act (21
U.S.C. 355, 360b, 382) or under section
351 of the Public Health Service Act (42
U.S.C. 262) (section 201(dd) of the
FD&C Act (21 U.S.C. 321(dd))).
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05981 Filed 3–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5470]
Real-World Evidence: Considerations
Regarding Non-Interventional Studies
for Drug and Biological Products; Draft
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 draft
guidance for industry entitled ‘‘RealWorld Evidence: Considerations
Regarding Non-Interventional Studies
for Drug and Biological Products.’’ FDA
is issuing this draft guidance as part of
a series of guidance documents under
its Real-World Evidence (RWE) Program
and to satisfy, in part, a mandate under
SUMMARY:
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20207
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to issue guidance about
the use of RWE in regulatory decisionmaking. The draft guidance provides
recommendations to sponsors who are
considering submitting a noninterventional study, also referred to as
an observational study, to FDA to
contribute to a demonstration of
substantial evidence of effectiveness
and/or evidence of safety of a drug. This
draft guidance was developed in
response to stakeholders’ growing
interest in the potential use of noninterventional studies to contribute to a
demonstration of the effectiveness or
safety of a drug.
DATES: Submit either electronic or
written comments on the draft guidance
by June 18, 2024 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
E:\FR\FM\21MRN1.SGM
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20208
Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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–5470 for ‘‘Real-World Evidence:
Considerations Regarding NonInterventional Studies 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
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)).
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Jkt 262001
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; 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 draft 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. 3326,
Silver Spring, MD 20993–0002, 301–
796–3161, dianne.paraoan@fda.hhs.gov;
or James Myers, 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 draft guidance for industry entitled
‘‘Real-World Evidence: Considerations
Regarding Non-Interventional Studies
for Drug and Biological Products.’’ This
draft guidance discusses attributes
regarding the design and analysis of a
non-interventional study that sponsors
should consider when proposing such a
study to contribute to a demonstration
of substantial evidence of effectiveness
and/or evidence of safety of a product.
Examples of non-interventional study
designs for evaluating the effectiveness
and/or safety of a drug include, but are
not limited to, cohort studies, casecontrol studies, and self-controlled
studies.
Identifying and addressing the
presence of confounding and other
forms of bias is critical when planning
and conducting non-interventional
studies. Before choosing a noninterventional study design for a study
intended to support regulatory decisions
regarding the safety and effectiveness of
a drug, sponsors should consider how
likely it is that such a study design and
its conduct will be able to distinguish a
true treatment effect from other
influences. The draft guidance assists
sponsors in identifying and addressing
commonly encountered challenges
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when considering the use of a noninterventional study to contribute to a
demonstration of substantial evidence of
effectiveness and/or evidence of safety
of a drug, including topics sponsors
should consider before developing a
prespecified protocol and statistical
analysis plan. This draft guidance
discusses the following major topics: (1)
summary of the proposed approach, (2)
study design, (3) data sources, and (4)
analytical approach. The topics in this
draft guidance should be considered in
conjunction with the recommendations
in other published guidances under the
RWE Program.
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 ‘‘Real-World Evidence:
Considerations Regarding NonInterventional Studies 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 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 21 CFR part 312
(investigational new drug applications)
have been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 (new
drug marketing applications) have been
approved under OMB control number
0910–0001; and the collections of
information in 21 CFR part 601 (biologic
license applications) have been
approved under OMB control number
0910–0338. The collections of
information in 21 CFR part 11
(electronic records and signatures) have
been approved under OMB control
number 0910–0303. The collections of
information in 21 CFR parts 50 and 56
(protection of human subjects and
institutional review boards) have been
approved under OMB control number
0910–0130.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05969 Filed 3–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1201]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary Total
Product Life Cycle Advisory Program
Pilot
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collections associated with Total
Product Life Cycle (TPLC) Advisory
Program (TAP) Pilot.
DATES: Either electronic or written
comments on the collection of
information must be submitted by May
20, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 20, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
lotter on DSK11XQN23PROD 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.
VerDate Sep<11>2014
16:53 Mar 20, 2024
Jkt 262001
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–
2024–N–1201 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Voluntary Total Product Life Cycle
Advisory Program Pilot.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
PO 00000
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20209
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://
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.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
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]]>Agencies
[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20207-20209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05969]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5470]
Real-World Evidence: Considerations Regarding Non-Interventional
Studies for Drug and Biological Products; Draft 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 draft guidance for industry entitled ``Real-World
Evidence: Considerations Regarding Non-Interventional Studies for Drug
and Biological Products.'' FDA is issuing this draft guidance as part
of a series of guidance documents under its Real-World Evidence (RWE)
Program and to satisfy, in part, a mandate under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of
RWE in regulatory decision-making. The draft guidance provides
recommendations to sponsors who are considering submitting a non-
interventional study, also referred to as an observational study, to
FDA to contribute to a demonstration of substantial evidence of
effectiveness and/or evidence of safety of a drug. This draft guidance
was developed in response to stakeholders' growing interest in the
potential use of non-interventional studies to contribute to a
demonstration of the effectiveness or safety of a drug.
DATES: Submit either electronic or written comments on the draft
guidance by June 18, 2024 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
[[Page 20208]]
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-5470 for ``Real-World Evidence: Considerations Regarding
Non-Interventional Studies 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 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 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; 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 draft 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. 3326, Silver Spring, MD 20993-0002, 301-
796-3161, [email protected]; or James Myers, 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 draft guidance for industry
entitled ``Real-World Evidence: Considerations Regarding Non-
Interventional Studies for Drug and Biological Products.'' This draft
guidance discusses attributes regarding the design and analysis of a
non-interventional study that sponsors should consider when proposing
such a study to contribute to a demonstration of substantial evidence
of effectiveness and/or evidence of safety of a product. Examples of
non-interventional study designs for evaluating the effectiveness and/
or safety of a drug include, but are not limited to, cohort studies,
case-control studies, and self-controlled studies.
Identifying and addressing the presence of confounding and other
forms of bias is critical when planning and conducting non-
interventional studies. Before choosing a non-interventional study
design for a study intended to support regulatory decisions regarding
the safety and effectiveness of a drug, sponsors should consider how
likely it is that such a study design and its conduct will be able to
distinguish a true treatment effect from other influences. The draft
guidance assists sponsors in identifying and addressing commonly
encountered challenges when considering the use of a non-interventional
study to contribute to a demonstration of substantial evidence of
effectiveness and/or evidence of safety of a drug, including topics
sponsors should consider before developing a prespecified protocol and
statistical analysis plan. This draft guidance discusses the following
major topics: (1) summary of the proposed approach, (2) study design,
(3) data sources, and (4) analytical approach. The topics in this draft
guidance should be considered in conjunction with the recommendations
in other published guidances under the RWE Program.
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 ``Real-World
Evidence: Considerations Regarding Non-Interventional Studies 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
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 21 CFR part 312 (investigational new drug applications) have been
approved under OMB control number 0910-0014; the collections of
information in 21 CFR part 314 (new drug marketing applications) have
been approved under OMB control number 0910-0001; and the collections
of information in 21 CFR part 601 (biologic license applications) have
been approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 11 (electronic records and signatures) have
been approved under OMB control number 0910-0303. The collections of
information in 21 CFR parts 50 and 56 (protection of human subjects and
institutional review boards) have been approved under OMB control
number 0910-0130.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/
[[Page 20209]]
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.
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05969 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P
