A Question Of Identity: Drug & Botanical Perspectives On Manufacturing Clash In Fulyzaq Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Salix’ botanical product Fulyzaq tested the limits of the conventional small molecule chemistry approach to ensuring the identity of drug substance. After a regulatory briefing with CDER Director Woodcock, the botanicals and CMC review teams agreed on a bioassay to bridge the gap in their regulatory perspectives.
You may also be interested in...
US FDA’s Botanical Drugs Guidance Will See Rare Outing For Amryt’s Filsuvez NDA
Amryt’s birch bark extract oleogel-S10 for Epidermolysis Bullosa patients might become only the third botanical drug to clear the FDA.
Review Of Reviews: Drug Review Profiles 2013
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.
Review Of Reviews: Drug Review Profiles 2013
Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2013.