Allphase Pharma Consulting, LLC
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You may be aware of recent food product recalls associated with food poisoning due to listeria contamination: ready-to-eat products, deli meats, sandwiches, protein snacks, chicken, turkey, cheese and dairy products. The list is long as Listeria is ubiquitous in the environment. One can find it in meat and milk/cheese products Continue reading LISTERIA: Food Recalls, Outbreaks, and Resistance
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