Benefit-Risk: Qualitative and Quantitative FDA/EU Approach & Frameworks

Benefit-risk assessments are required for informed decision making during early product development, device/diagnostic approval applications, PMS, PSUR and for ad hoc assessments to address new safety concerns.

In the last two decades there has been a shift in the approach to evaluating the benefit-risk (BR) profiles of products from an unstructured, subjective, and inconsistent, to a more structured and objective process.