GMP Qualification And Testing Provisions Still Trip Supplement Firms
This article was originally published in The Pink Sheet Daily
Though the majority of warning letter recipients are smaller enterprises, large companies are not immune, and with examples mounting it's hard to plead ignorance of agency expectations.
You may also be interested in...
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
With an unrestricted label and once-daily dosing, rivaroxaban will do battle with Boehringer-Ingelheim's dabigatran, which is dosed twice a day but can claim superior efficacy to warfarin in the atrial fibrillation population.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.