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

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

Making The News:  Something Hilarious, Something Ominous…

Hilarious:  Chicks and Kids Antibiotic use in animals is defended as infection prophylaxis, but the honest reason why chickens are exposed for most days of their short life to antibiotics of various kinds is for growth promotion.  Antibiotic use keeps those chicks healthy which in turn makes them eat more Continue reading Making The News:  Something Hilarious, Something Ominous…

Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

VABP is clearly the main indication to be pursued by a drug like POL7080.  Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum?  Which is actually no spectrum at all.  Existing guidelines for the development of ID drugs are indication-driven, with Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)