Advancing Real-World Evidence Program

https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program?utm_medium=email&utm_source=govdelivery#:~:text=As%20announced%20in%20the%20Federal%2cnew%20indications%20of%20approved%20medical The deadline for the eighth submission cycle of the U.S. Food and Drug Administration’s Advancing Real-World Evidence (RWE) Program is September 30, 2026. Of note, FDA has also updated the frequently asked questions section of the Advancing RWE Program website.   For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in CDER, CBER, and OCE, 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. Advancing Real-World Evidence Program Frequently Asked Questions https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program-frequently-asked-questions?utm_medium=email&utm_source=govdelivery