Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

What Better Gout Trials Might Look Like

Executive Summary

FDA comments in Ironwood's Zurampic review suggest what the agency would like to see from gout clinical programs.

You may also be interested in...



Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews

The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.

With Zurampic, FDA Again Made Do With Sorry State Of Regulatory Science In Gout

Zurampic, which AstraZeneca licensed to Ironwood, pushed the limits of FDA's tolerance of the regulatory compromises agency has had to make in gout; our Drug Review Profile shows how statistician's case against approval received serious consideration, although the agency ultimately valued consistency with previous approvals in the space.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118952

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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