[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63786-63787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program.

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, [email protected], 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, 
[email protected], 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


