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New Treatment Guidelines for Candidiasis – A Major Document to Study

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In a much-quoted analysis, Lee found that most IDSA Guidelines were supported only by Level III quality data, the lowest category of evidence-based support[1]. The article concludes that more well-designed trials were needed, and clinical judgement should ultimately guide patient management. This all sounds fine and good, and the new Continue reading New Treatment Guidelines for Candidiasis – A Major Document to Study→

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→