FDA Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing
This article was originally published in The Pink Sheet Daily
Executive Summary
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...
FDA Supplement GMP Crosshairs More Frequently On Smaller Firms
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.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
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.
Bayer/J&J's Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa
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.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: