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

How To Save A Drug: Iressa’s Return Relied On Consistency Across Totality Of Evidence

Executive Summary

Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.

You may also be interested in...



Keeping Track Of Good News For AstraZeneca, Pfizer, Promius, And Sunovion

NDA and BLA submission news from our US FDA Performance Tracker.

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL111109

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