Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA
The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary endpoint. FDA made other significant changes to the old 1998 Continue reading Commenting on Comments: The Ceftaroline Trial Program in CABP
The treatment history of N. gonorrhoeae makes for fascinating reading. This organism has always been able to keep the upper hand in the war of bug versus drug. Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially become resistant in the matter of a decade to every Continue reading A GO / NO GO decision: Delafloxacin Stumbles in Gonorrhea Study