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

Amgen’s Nplate Has First Mandatory Patient Registration Under REMS

Executive Summary

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

You may also be interested in...



Finally, A REMS FDA Could Live With

"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.

REMS For Opioids: Industry Considering Prescriber, Dispenser Certification

Drug makers have agreed on communications, education components of strategy.

Telavancin’s “Complete Response” Letter Calls For Pregnancy-Focused REMS

After a three-day, three-drug advisory committee in November, the last sponsor standing - or at least the last to get a "complete response" letter from FDA - may be in the best position to move forward with its complicated skin and skin structure infections antibiotic

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS050110

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