Home » The Viewpoint » Page 16

Category Archives: The Viewpoint

Ops Page for Editorials, and …Opinions

A Critical Review of WHO’s List of Antibacterials in Clinical Development

Posted on by — No Comments ↓

WHO compiles a list of antibacterials in clinical development on a regular basis, the last in mid-2024 [1].  The information is up-to-date and detailed: it provides MoA and antibacterial spectrum, coverage of problem pathogens, the development phase, and whether it can be considered an ‘innovative’ drug (based on a set Continue reading A Critical Review of WHO’s List of Antibacterials in Clinical Development→

The Weak Correlation Between Antibiotic Action and Mortality

Posted on by — No Comments ↓

At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the most important clinical endpoint[2]. FDA felt so strongly about this, Continue reading The Weak Correlation Between Antibiotic Action and Mortality→

FDA Needs Radical Reform

Posted on by — 2 Comments ↓

The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All the while FDA lobbyists are singing the praises of an Continue reading FDA Needs Radical Reform→