FDA Opens Applications for PDUFA VII Real-World Evidence Programs

The US Food and Drug Administration (FDA) will start accepting applications for two programs that are part of the Prescription Drug User Fee Act (PDUFA VII). These programs are intended to help improve the use of real-world evidence (RWE) in approvals for new therapeutics. In addition, the program is set to promote novel clinical trial designs.

According to Ferdous Al-Faruque, “Sponsors with an investigational new drug (IND) or pre-IND, those with proposed RWE intended to meet regulatory requirements for how to present effectiveness in labeling and those who agree to publicly present their study designs may be eligible for the program. FDA specifically notes that lessons learned from the program, such as new study designs, may be presented at future FDA public forums and in guidances. However, the agency is only initially accepting a small number of sponsors for the program due to resource constraints.”

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(Source: Regulatory Focus, October 19^th, 2022)