Tag Archives: fluoroquinolone

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

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Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in light of new post-approval safety issues. The document is 617 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1→

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→

Nominating Thiamphenicol for IDSA’s 10 x ’20 Campaign

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If you were developing a new antibiotic with a novel MoA, one that covers most GPC, most GNR, most anaerobes and atypicals, including many MDR pathogens like MRSA, enterococci (both E. faecalis and E. faecium), and one that has also activity against rickettsiae and bioterrorism agents, you would consider it a Continue reading Nominating Thiamphenicol for IDSA’s 10 x ’20 Campaign→