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

FDA's Brilliant Management of Avandia Re-Review Provides Flexibility on Final Decision

This article was originally published in RPM Report

Executive Summary

Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.

You may also be interested in...



FDA Using Medicare Data Linked to NCI Databases to Look at Cancer Signals

FDA is looking at linking Medicare data to National Cancer Institute registries to enhance the information from medical claims data and gain a better understanding of disease-cancer and drug-cancer relationships. A familiar figure from FDA epidemiological work is keenly involved: safety officer David Graham.

FDA’s Go-To Statistician: UW’s Fleming Holds Court At Xifaxan Advisory Committee Meeting

University of Washington statistician Thomas Fleming seems to be showing up more often on FDA advisory committees and is having an outsized impact on the meetings.

Bristol-Myers Squibb/AstraZeneca Onglyza is Guinea Pig for FDA Mini-Sentinel Post-Market Surveillance

FDA’s Congressionally-mandated active surveillance system, Sentinel, is ready for shakedown cruises in 2011. One of the first projects will be a close examination of real-world experience and cardiovascular events associated with saxagliptin. That’s a dubious distinction for BMS/AZ, the co-marketers of Onglyza–but it also sets up a new dynamic that all sponsors should watch.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS080720

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