Benefit-risk assessment is the foundation for FDA’s regulatory review of human drugs and biologics. These assessments capture the Agency’s evidence, uncertainties, and reasoning used to arrive at its final determination for specific regulatory decisions. Additionally, they serve as a tool for communicating this information to those who wish to better understand FDA’s thinking.

Beginning with commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), the Agency has identified and implemented enhancements with the goal of increasing the clarity, transparency, and consistency of FDA’s benefit-risk assessments in human drug review. With passage of the 21st Century Cures Act, FDA also has an imperative to consider how relevant patient experience data and related information can be incorporated into the structured benefit-risk assessment framework to inform regulatory decision-making. This page contains information related to FDA’s implementation and ongoing enhancement of benefit-risk assessment in human drug and biologic regulatory decision-making.

PDUFA VI

• Benefit-Risk Assessment in Drug Regulatory Decision-Making

PDUFA V

• Draft PDUFA V Implementation Plan: Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making
• PDUFA V Benefit-Risk Plan; Request for Comments
• Public Workshops on Benefit-Risk Considerations

ResourcesForYou

• PDUFA V: Fiscal Years 2013 - 2017
• PDUFA VI: Fiscal Years 2018 - 2022
• CDER Patient-Focused Drug Development