For Industry

Enhancing Benefit-Risk Assessment in Regulatory Decision-Making

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.


As part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title 1 of the FDA Reauthorization Act of 2017, FDA has committed to furthering the Agency’s implementation of structured benefit-risk assessment into the human drug review program. FDA has made several commitments in PDUFA VI for continued implementation of structured benefit-risk assessment during FY 2018–2022.


As part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), FDA’s Center for Drug Evaluation and Research and Center for Biologics and Research committed to furthering FDA’s efforts to enhance benefit-risk assessment and communication in the human drug and biologic review process. The keystone commitment in PDUFA V was to implement FDA’s Benefit-Risk Framework into the regulatory review processes and documentation.

Page Last Updated: 03/30/2018
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