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


Finally, A REMS FDA Could Live With

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

"It took us three months" to negotiate with FDA on the fine points of the REMS and make the refinements required to finalize the document, Amgen safety exec Rekha Garg told the recent Post-Approval Summit at Harvard.

You may also be interested in...

Amgen’s Nplate Has First Mandatory Patient Registration Under REMS

The Risk Evaluation and Mitigation Strategy for Amgen's platelet producer Nplate mandates enrollment at three levels of a controlled distribution system: institutions, physicians and patients

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals






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