Cooperative Agreement to Support Regulatory Research Related to the 2023 Prescription Drug User Fee Act


The goal of this collaboration is to advance research in several key areas of interest to FDA and external stakeholders by convening stakeholders with diverse expertise, and to inform and support the advancement of regulatory science priorities, particularly those identified in PDUFA VII. There will be substantial Federal scientific or programmatic involvement in assisting, guiding, coordinating, and participating in project activities, which makes a cooperative agreement the most appropriate mechanism.