Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for the next new B-lactam or quinolone regardless of whether during Continue reading Profiling Solithromycin: FDA AMDAC on Solithera
The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes
Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that patients and the scientific community have a right to this Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably