Profiling Solithromycin: FDA AMDAC on Solithera

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 Continue reading Profiling Solithromycin: FDA AMDAC on Solithera

A Patch? YES – A Fix? NO: This Emperor Has No Clothes

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 Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes

Moving Towards Greater Transparency – One Step At A Time, Inexorably

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 Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably

Brilacidin – QIDP Drug At a Critical Juncture

At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a Continue reading Brilacidin – QIDP Drug At a Critical Juncture

And the Results are …Pending

The website “ClinicalTrials.gov” has become the first stop for many of us who need to check on trial activity of a particular drug.  All larger human Phase 2 – 4 trials are listed there in quite some detail.  While companies Continue reading And the Results are …Pending