2022-22795. Advancing Real-World Evidence Program

AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notice.

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, [e-mail], 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, [e-mail], 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/​ 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.