TL33: Practices on Benefit-risk Assessment
*Hong Laura Lu, CDRH/FDA 


The outcome of the benefit/risk assessment will determine the approvability of a durg/device. Evaluation on benefit/risk ratio through clinical judgement and stsititical analyses were widely discussed and produced a lot of publications in recent years. In this session, we will discuss the methods that are actually applied in practice and how useful/informative the proposed methods are.