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 Continue reading FDA Needs Radical Reform
Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
The cartilage damage caused by fluoroquinolones in juvenile beagle dogs is not subtle: blister formation and erosions occur in a dose-dependent fashion resulting in reversible cartilage damage. These lesions can be seen not just histologically but even macroscopically. The animals Continue reading The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm