The deadline for the second submission cycle of the FDA Advancing Real-World Evidence (RWE) Program is September 30, 2023. FDA has also updated the Advancing RWE Program website to include a section addressing frequently asked questions the agency received during the Advancing RWE Program’s first submission cycle, ending on March 31, 2023.
For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Oncology Center of Excellence—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 the agency will continue to be available.
For more information on the program, visit the Advancing Real-World Evidence Program webpage.
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