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

How FDA Withdraws A Drug

This article was originally published in RPM Report

Executive Summary

FDA is weighing whether to pull GlaxoSmithKline's Avandia and Abbott Laboratories' Meridia off the market. Past examples demonstrate the final decision on whether to remove a drug or keep it on the market is a messy process made by a select number of government officials.

You may also be interested in...



The Future of Drug Regulation: An Interview With Center for Drug Evaluation & Research Director Janet Woodcock

FDA’s top drug regulator sat down for us for an interview about the agency’s efforts to build a higher quality regulatory system in the US—one that focuses on the “content” of regulatory standards rather than just the process. The discussion touched on the need for new and improved standards in classes like weight loss and rheumatology (albeit for very different reasons); the characteristics that make for good drug reviewers (and their managers); and on the drug center’s responsibility for preserving private sector drug development.

Accelerated Withdrawal in Action: The Avastin Hearing Process

The June hearing on the status of Genentech’s metastatic breast cancer indication for Avastin will focus on a long list of substantive disagreements about the data. But any sponsor interested in the future of the accelerated approval process should study the back-and-forth in the hearing process itself.

Lessons Learned: How Avandia is Changing the Way FDA Does Business

FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080737

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