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 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!

Best wishes,

–jr

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

Share

17 April 2023: FREE Masterclass from FDA / CARB-X wants you!

Dear All, Two quick items today. First, FDA have announced an Antimicrobial Drugs Advisory Committee on 17 April 2023 (9a-4.30p ET). The committee will “discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and

WHO 2023 Pipeline Update: Share Your Preclinical Antibacterial Projects!

Dear All, As you know, WHO updates their preclinical and clinical pipeline summaries at regular intervals. The most current reviews are summarized on https://amr.solutions/pathogens-and-pipelines/. These excellent summaries are invaluable for researchers of all types and are also used to inform policy work. There is now a call to for current information on antibacterial pre-clinical projects. Go here

PASTEUR: Sign a letter to make it happen this year!

Dear All, As all regular readers of this newsletter know, I think that creation of suitable Pull incentives by passage of the PASTEUR Act in the United States is THE key to building a vibrant pipeline of products to address the international problem of AMR. PASTEUR came very close to passage at the end of 2022 …

Scroll to Top