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The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

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Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?→

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→

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

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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)→