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Here an updated listing of all QIDP drugs we are aware of as of 12/24/2015. Today just facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are 58 drugs which garnered QIDP status and these are listed in the Main Table below. With the recent Continue reading QIDP Antibiotics – 2015 Year-End Update
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?
When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards. Take colistin as an example: approved in the early 60ies, we still Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny