ABSTRACT
As highlighted throughout this book, assessing the benefit-risk (B-R) balance or profile of treatment options, be they drugs, devices, or procedures, is a prominent challenge across the spectrum of healthcare and drug development. B-R assessments have been conducted since the modernization of the drug regulatory system in the wake of the 1960s thalidomide disaster; however, it has only been within recent years that progress has been made on apposite methodologies for conducting formal assessments.1-5 Chapter 7 provided a concise review of policy development; this chapter reviews progress made toward implementing structured and consistent approaches to B-R assessment. It highlights key developments in systematic B-R assessment.
