Pink Sheet is part of the Business Intelligence Division 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


FDA, EMA Decisions On Avandia Reflect The Power Of REMS

Executive Summary

Contrasting decisions by FDA and the European Medicines Agency on the fate of GlaxoSmithKline’s Avandia reflect not so much a divergence of scientific opinion between the two regulators, but rather differences in how they chose to manage the drug’s cardiovascular risks and the tools available for doing so.

Related Content

Avandia REMS Requires Doctors To Tell Patients About Actos’ CV Safety
"The Pink Sheet" – Most Notable Stories Of 2010
FDA Seeks Dedicated Meta-Analysis Team As Part Of PDUFA V User Fee Funding
Cardiac Risks Of Propoxyphene Raced Out Of Control As FDA Moved For Immediate Withdrawal
REMS 2.0: FDA Refining New Drug Safety Tools
Avandia Shows FDA Discomfort With Meta-Analyses, Observational Studies In Decision-Making
Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views
FDA Keeps Avandia On The Market But Looks To RECORD For More Clarity On CV Risk
EU Suspends Avandia; Pressure On Open Decision-Making May Stay
Avandia Advisory Committee Re-Review Reflects Well On FDA





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