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

ESA Labeling Should Explain Hemoglobin Target, Advisory Committee Says

Executive Summary

Treatment targets for erythropoiesis-stimulating agents in the renal setting need to be accompanied by clinical management information, FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees says

You may also be interested in...



Amidst ESA Upheaval, FDA Used Mircera Review To Outline Trial “Wish List”

FDA's review of Roche's Mircera BLA became a forum for the agency to set forth a "wish list" for future development of erythropoietin stimulating agents that reflected the seismic upheavals in the conventional understanding of the safety of erythropoietin products

Amidst ESA Upheaval, FDA Used Mircera Review To Outline Trial “Wish List”

FDA's review of Roche's Mircera BLA became a forum for the agency to set forth a "wish list" for future development of erythropoietin stimulating agents that reflected the seismic upheavals in the conventional understanding of the safety of erythropoietin products

Amgen, J&J Propose New Target Range For Aranesp, Procrit

Just a year after FDA removed information related to a dosing target range for erythropoiesis-stimulating agents from product labeling, Amgen and Johnson & Johnson are proposing to re-establish a specific hemoglobin target range for the anemia therapies

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS048791

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