FDA taskforce: helpful guide or obstructive box-ticker?
This article was originally published in Scrip
Executive Summary
Prompted by a diminishing pipeline, the FDA has formed a new taskforce to support the development of antibacterial drugs. While this is a positive move, there are questions as to whether this is a serious refocus or simply another case of rehashing FDA guidances to produce unfeasible clinical trials that have previously caused promising - and effective - drugs to be lost or stuck in the pipeline.