Commenting on Comments: The Ceftaroline Trial Program in CABP
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