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 open access, so you’ll have to download yourself).
When the B-R material was released in 2015, I’ll confess that I did not see the full potential of the idea. But, since then we’ve seen emergence of greater clarity around the adaptive pathway (EMA) and then most recently LPAD (FDA). Put in the context of that background, the idea of applying a structured B-R analysis suddenly takes on a new immediacy.
Food for thought as you progress a narrow-spectrum agent!
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx