Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
It can feel like the mountain stage of the Tour de France… A lot of effort goes into preparing for meetings with Regulators. There is also a lot we can learn at such meetings. Today we start a series of blogs detailing personal experiences and learnings, highlighting do’s and don’ts. Continue reading REGULATORY INTERACTIONS – 1
Despite all the concern about the emergence of CRE pathogens worldwide, it is quite difficult to obtain hard quantitative, prospectively collected incidence figures. A recent article by Robert [1] and colleagues provides useful data from France. Using a practical definition of carbapenem-non-susceptibility (ertapenem > 0.5, imipenem, meropenem > 2, doripenem > 1), Continue reading CRE Surveillance Data from France