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

US FDA Advisory Panel Split On Value Of Education In Fentanyl REMS

Executive Summary

Some members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further education will be useless in ensuring the REMS meets its goals. 

You may also be interested in...



Asleep At The Switch? FDA’s TIRF REMS May Not Be A Model After All

The recent US advisory committee review of the Transmucosal Immediate-Release Fentanyl REMS program is important as another marker of the fraught climate around prescription opioid abuse. But it may have broader implications for the future of drug safety regulation and the REMS model.

Subsys Makes A Bad Impression On FDA REMS Panel Members

CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.

Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA

Advisory committee panelists divided on whether to modify REMS for TIRF products to reduce their wide-ranging off-label use.

Topics

UsernamePublicRestriction

Register

PS123669

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