Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement

Related Content

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS005411

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel