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 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 Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny
If you were developing a new antibiotic with a novel MoA, one that covers most GPC, most GNR, most anaerobes and atypicals, including many MDR pathogens like MRSA, enterococci (both E. faecalis and E. faecium), and one that has also Continue reading Nominating Thiamphenicol for IDSA’s 10 x ’20 Campaign