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

UsernamePublicRestriction
UsernamePublicRestriction

FDA and ESA Safety: A Conversation with Bob Temple and Ellis Unger

This article was originally published in RPM Report

Executive Summary

The cardiovascular risks associated with ESAs in the renal disease population are being reevaluated by FDA with the outcome of three clinical trials now in hand. The agency is considering a number of issues as it decides what to do with these therapies

You may also be interested in...



The ESA Disconnect Between FDA and CMS

Another major decision is looming at CMS on whether to open up a national coverage analysis for ESAs in the renal disease area-a MEDCAC meeting appears to be the first step. The Medicare agency previously jumped out in front of FDA on a coverage decision in the oncology setting. This time, it appears that CMS will wait to hear what FDA has to say. But FDA isn't paying much attention to CMS.

The ESA Disconnect Between FDA and CMS

Another major decision is looming at CMS on whether to open up a national coverage analysis for ESAs in the renal disease area-a MEDCAC meeting appears to be the first step. The Medicare agency previously jumped out in front of FDA on a coverage decision in the oncology setting. This time, it appears that CMS will wait to hear what FDA has to say. But FDA isn't paying much attention to CMS.

The Rebirth of A Niche Product: Three Silver Linings on the ESA REMS

The long-awaited Risk Evaluation & Mitigation Strategy for Aranesp and Procrit is here. For the oncology indication, it requires provider training program enrollment. It may not seem like the best outcome for Amgen and J&J, but there are some upsides.

Related Content

Related Companies

UsernamePublicRestriction

Register

PS080681

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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