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

Avandia's TIDE May Come In Smaller

This article was originally published in The Pink Sheet Daily

Executive Summary

Two advisory panels recommended that FDA allow the trial of GlaxoSmithKline's Avandia (rosiglitazone) to continue but questioned its design, providing important hints for drug companies planning post-marketing safety trials in the future.

You may also be interested in...



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.

Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views

In deciding to keep GlaxoSmithKline PLC’s Avandia on the market, while also heavily restricting its use, FDA Center for Drug Evaluation and Research Director Janet Woodcock split the difference between opposing recommendations from the Office of New Drugs and Office of Surveillance and Epidemiology.

Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views

In deciding to keep GlaxoSmithKline PLC’s Avandia on the market, while also heavily restricting its use, FDA Center for Drug Evaluation and Research Director Janet Woodcock split the difference between opposing recommendations from the Office of New Drugs and Office of Surveillance and Epidemiology.

Related Content

Topics

UsernamePublicRestriction

Register

PS070892

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