Allphase Pharma Consulting, LLC
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Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for Continue reading Profiling Solithromycin: FDA AMDAC on Solithera
Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004. Pfizer acquired dalbavancin as a “Phase 3 completed” Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing
Looking across the Northern border it is clear that CDC Guidelines are not universally followed even in North America. Public Health Canada still recommends cefixime for uncomplicated gonorrhea (GC), albeit at the high single oral dose of 800 mg [1]. In Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (1)