Final FDA Unmet Need Guidance!

Dear All: 

Just out in the last 24h is the announcement that FDA’s 2013 Unmet Need Guidance has now been released in final form. The associated FR guidance is also worth reading as it provides a summary of what has been updated:

“This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR 39737). After consideration of comments received in response to the draft guidance, FDA updated the guidance to include clarifications about trial designs for streamlined development programs and statistical approaches. In addition, the guidance outlines development approaches for antibacterial drugs that are pathogen-focused (i.e., drugs that are intended to treat a single species or a few species of bacteria) and, accordingly, fulfills the requirements of section 806(a), Title VIII (entitled “Generating Antibiotic Incentives Now”) of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144).”

As always, it takes a while to absorb everything in a guidance and I’ll also confess that I’m at the beach right now. So, I am going to limit my comments today to simply observing that the document is a very natural extension of the discussions we’ve been having via various recent workshops. In particular, there is a lot added clarity on pathogen-focused drugs, use of data from multiple body sites, and possibly alternative statistical approaches. For additional color, you might like to read my note about the 13 Apr 2017 FDA Advisory Committee on narrow-spectrum agents for P. aeruginosa and A. baumannii.

Many thanks again to our FDA colleagues for working so diligently to advance this discussion. And, it appears that there is more to come … the FR notices states that a specific guidance on LPAD is being drafted as well.

All 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. See past newsletters and subscribe for the future:

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