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

The Anti-Avandia: Phenytoin, Purple Glove Syndrome, and the Eternal Challenge of Drug Safety

This article was originally published in RPM Report

Executive Summary

A look at how FDA handles drug safety when the world isn’t watching. Even without the drama, drug safety issues are never easy.

You may also be interested in...



Vytorin: Yesterday’s News?

Merck’s cholesterol drug is poised to add a unique claim to improve outcomes in as many as 19 million Americans, even though there still isn’t data to answer critics about whether ezetimibe actually adds clinical benefit to conventional statin therapy. Why doesn’t anyone seem to care?

Avandia Revisited: Will New Findings Lead To Reevaluation of Drug Center's Structure?

Senate Finance Committee report and internal FDA analysis on cardiovascular risks associated with GSK's Avandia may revive argument to split CDER into two groups of safety and efficacy reviewers.

Avandia and the Commercial Impact of FDA's Credibility Gap

GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080765

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