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

FDA Draws Upon New Authority To Mandate Elements OF ESA Labeling

Executive Summary

FDA and the sponsors of erythropoiesis-stimulating agents were mostly able to reach an agreement on safety revisions to labeling of the anemia therapies, but the agency was forced to employ its new regulatory authority to resolve a couple points of continued disagreement

You may also be interested in...



Affymax's Peginesatide May Be Tough Sell To ODAC As ESAs Cast Long Showdow

Safety concerns over erythropoiesis-stimulating agents seem to extend to Affymax's peginesatide, and since it lacks an efficacy edges over these drugs in treating anemia due to chronic kidney disease, an approval basis is unclear.

Class-Wide Rx Safety Issues Are Focus Of FDA Guidance On New Label Change Powers

FDA is emphasizing a class-based approach to requiring safety-related drug labeling changes under the FDA Amendments Act.

Class-Wide Rx Safety Issues Are Focus Of FDA Guidance On New Label Change Powers

FDA is emphasizing a class-based approach to requiring safety-related drug labeling changes under the FDA Amendments Act.

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS049944

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