PDUFA VII was signed into law on September 30, 2022. The associated PDUFA VII goals letter was negotiated by the FDA, with input from patient advocacy groups and industry stakeholders and builds upon previous iterations with a renewed focus on strengthening FDA’s critical capabilities, improving efficiencies in drug review and driving innovation for patients. The PDUFA VII goals letter addresses new areas such as advancing digital health technologies, enhancing product quality reviews and facilitating increased utilization of innovative manufacturing technologies. The current user fee authorization expires September 2027.
Key areas of the PDUFA VII goals letter include: