Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance 2020

Eileen Wu and Judith Zander from CDER’s Office of Pharmacovigilance and Epidemiology (OPE) describe risk-based principles, available tools, and methods for postmarket safety surveillance. They provide the fundamentals of benefit-risk assessment in the drug regulatory context, with an introduction to the FDA’s Benefit-Risk Framework and its implementation into postmarketing processes.
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