Benefit-Risk analyses: Gassman et al. (NEJM) + FDA
Dear All: An article by Gassman, Nguyen, and Joffe in today’s NEJM entitled “FDA regulation of prescription drugs” caught my eye because of its emphasis on structured benefit-risk (B-R) analyses as a core part of regulatory thinking. See links below along with the core paper from the FDA’s website on benefit-risk (oddly, the NEJM paper is not