FDA Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing
This article was originally published in The Pink Sheet Daily
FDA dietary supplement good manufacturing practices final rule places the onus of compliance completely on manufacturers, with any dietary ingredient used in a supplement required to pass "100 percent" identity testing.
You may also be interested in...
GMP violation warnings to three small dietary supplement firms in late March reflect a “thoughtful shift” by FDA toward inspections of smaller firms, says UNPA President Loren Israelsen. With the supplement GMP final rule past its 10-year anniversary, firms should be meeting their requirements.
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.