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Commenting on Comments:  The Ceftaroline Trial Program in CABP

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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→

FDA Adboard on Tedizolid – Why?

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FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair:  Looking at the reviewer’s slides, there was really no question about the drug’s efficacy.  Did tedizolid cure as many patients as linezolid?  Yes, it did.  Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority?  Yes, they Continue reading FDA Adboard on Tedizolid – Why?→