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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.

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