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


The FDA Roundtable Part II: REMS, Outcomes Studies and Drug Withdrawals

This article was originally published in RPM Report

Executive Summary

In Part II of The RPM Report’s roundtable discussion with three top FDA officials, the importance and implementation of FDA’s new REMS authorities, drug withdrawal precedents and the agency’s view of outcomes studies are the focus of the discussion.

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.

Diabetes Drug Development: Post-Avandia

There are new considerations for developing diabetes drugs when it comes to FDA's expectations. Here are some of the questions to consider.

GSK Goes To The Heart Of The Problem With Outcomes Study For Darapladib

GlaxoSmithKline is applying a lesson the pharmaceutical industry learned from recent events in cardiovascular drug development: do an outcomes study, and start it early

Related Content


Related Companies

Latest Headlines
See All



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