Notice2022-22795
Advancing Real-World Evidence Program
Primary source
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Published
October 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the Advancing Real-World Evidence (RWE) Program to fulfill FDA's commitment under the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022.
Full Text
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<title>Federal Register, Volume 87 Issue 202 (Thursday, October 20, 2022)</title>
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[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63786-63787]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22795]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2455]
Advancing Real-World Evidence Program
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the Advancing Real-World Evidence (RWE) Program to fulfill FDA's
commitment under the seventh iteration of the Prescription Drug User
Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee
Reauthorization Act of 2022.
DATES: The Advancing RWE Program will proceed from the date of this
notice through September 30, 2027. Sponsors may submit meeting requests
for the program through March 31, 2027.
ADDRESSES: For additional information about the Program, please refer
to FDA's web page at <a href="https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program">https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program</a>.
FOR FURTHER INFORMATION CONTACT: Nahleen Lopez, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6360, Silver Spring, MD 20993-0002, 240-
402-2659, <a href="/cdn-cgi/l/email-protection#abe5cac3c7cecec585e7c4dbced1ebcdcfca85c3c3d885ccc4dd"><span class="__cf_email__" data-cfemail="e7a9868f8b828289c9ab8897829da7818386c98f8f94c9808891">[email protected]</span></a>, with the subject line ``Advancing
RWE Program''; or 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,
<a href="/cdn-cgi/l/email-protection#55062130253d303b7b073c2539302c153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="7d2e09180d151813532f140d1118043d1b191c5315150e531a120b">[email protected]</span></a>, with the subject line ``Advancing RWE
Program.''
SUPPLEMENTARY INFORMATION:
I. Background
In connection with the seventh iteration of the Prescription Drug
User Fee Amendments (PDUFA VII), incorporated as part of the FDA User
Fee Reauthorization Act of 2022, FDA committed to establishing the
``Advancing Real-World Evidence (RWE) Program,'' which seeks to
identify approaches for generating RWE that meet regulatory
requirements in support of labeling for effectiveness (e.g., new
indications, populations, dosing information) or for meeting post-
approval study requirements. FDA is establishing and publicly
communicating the Advancing RWE Program to satisfy this commitment. The
Advancing RWE Program provides sponsors who are selected into the
Program the opportunity to meet with Agency staff--before protocol
development or study initiation--to discuss the use of RWE in medical
product development. The Advancing RWE Program is an optional pathway
for sponsors submitting RWE proposals; established procedures to engage
with the Agency will continue to be available.
Meetings under the Advancing RWE Program will be conducted by FDA's
Center for Drug Evaluation and Research (CDER) or Center for Biologics
Evaluation and Research (CBER) during fiscal years 2023 to 2027.
Oncology applications will include participation from the Oncology
Center of Excellence. FDA will grant up to four meetings between CDER
or CBER and a sponsor selected into the Advancing RWE Program to
discuss approaches for generating RWE that can meet regulatory
requirements. To promote awareness of characteristics of RWE that can
support regulatory decisions, study designs discussed through the
program may be presented by FDA in a public forum (e.g., in a guidance
or public workshop).
The Advancing RWE Program website includes current program
eligibility criteria; format, content, and instructions for submission
of initial and followup meeting requests; and information regarding a
required disclosure agreement. The Program's website address is https:/
/www.fda.gov/drugs/development-resources/
[[Page 63787]]
advancing-real-world-evidence-program.
II. Paperwork Reduction Act of 1995
This notice refers to collections of information that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information resulting from formal meetings between sponsors or
applicants and FDA have been approved under OMB control number 0910-
001. The collections of information in 21 CFR part 312 (investigational
new drug applications) have been approved under OMB control number
0910-0014.
Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22795 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P
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