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FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review
Session Chair(s)
Graham Thompson
Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER
FDA, United States
FDA will present an overview of considerations on benefit-risk assessment across the drug development lifecycle and solicit input from session attendees.
Learning Objective : Explain FDA’s approach to benefit-risk assessment throughout the lifecycle of drug development; Identify important milestones along the drug development lifecycle for communication between FDA and stakeholders on key considerations for regulatory benefit-risk assessment; Describe how early planning should be considered to collect data that may inform benefit-risk assessment.
Speaker(s)
Key Considerations and Patient Experience
Kerry Jo Lee, MD
FDA, United States
Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro
Benefit-Risk Planning and Statistical Considerations
Gregory Levin, PhD
FDA, United States
Associate Director for Statistical Science and Policy, OB, OTS, CDER
Post Market Benefit-Risk Considerations
Judith Zander, MD
FDA , United States
Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
Additional Analysis to Inform Benefit-Risk Assessment
Hong Yang, PhD
FDA, United States
Biologist, OBPV, CBER
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