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

Avandia Trial Re-Adjudication Beyond FDA’s Abilities, Agency Officials Say

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA had only a portion of the information needed to conduct a re-adjudication, Bob Temple tells advisory committee during the first of a two-day discussion of rosiglitizone’s cardiovascular safety.

You may also be interested in...



Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety

Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.

Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner

A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.

Avandia Advisory Committee: Can Poking Old Wounds Be Good For FDA?

Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS075916

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