Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications: Lessons Learned

Conclusions:
Sponsors can apply these approaches to incorporate benefit-risk assessments into their marketing authorization applications. Further shared learnings and benchmarking among the pharmaceutical industry will be necessary to further advance the science and practice of benefit-risk assessment.

Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Wang, J., Wolka, A., Bullok, K., Anglin, G., Radawski, C., Noel, R. Tags: Regulatory Science Source Type: research