Allphase Pharma Consulting, LLC
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David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”. He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS
Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA