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

Comparative Effectiveness Reaches Into Drug Reviews, FDA Documents Show

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As the health care reform debate focuses on the appropriate role of comparative effectiveness research, a look at FDA’s review practices gives some insight into how the agency already takes the concept into account in its review decisions.

You may also be interested in...



AstraZeneca's Motavizumab May Be The Canary In The Follow-On Coal Mine

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC’s motavizumab, which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. This suggests the government agency’s standards may be changing on a range of issues, from comparative effectiveness to data integrity.

AstraZeneca's Motavizumab May Be The Canary In The Follow-On Coal Mine

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC’s motavizumab, which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. This suggests the government agency’s standards may be changing on a range of issues, from comparative effectiveness to data integrity.

Would AstraZeneca Be Better Off If Rezield Had Gotten A Harsher FDA Letter?

AstraZeneca subsidiary MedImmune received a "complete response" letter from FDA for its RSV drug motavizumab that did not request additional clinical data, but after an unfavorable advisory committee a year and a half later, the company is looking at the prospect of having to do another trial anyway

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS004305

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