Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The 1st edition of Mandell’s textbook ‘Principles and Practice of Infectious Disease’ was published in 1979. It has grown ever since in size and numbers of chapters. Now in its 10th edition, it is and remains an impressive publication, a 2-volume set, a comprehensive reference textbook, kept up-to-date with periodic Continue reading Where are the Chloramphenicol Derivatives?
Statements that have the words ‘FDA’ and ‘flexibility’ in a single sentence need to be approached with some skepticism. Especially if made by the Agency. ‘Flexibility’ always sounds better than ‘less rigidity’. Regulators are tasked with providing a certain sense of consistency or stability in the drug development jungle where Continue reading The New Default: 1 (One) Single Pivotal Trial
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