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

Opioid REMS Prescriber Education Should Be Mandatory, FDA Panel Says

This article was originally published in The Pink Sheet Daily

Executive Summary

This time, the agency may be ready to agree with its advisory committee.

You may also be interested in...



Opioid REMS: New CME 'Blueprint' To Include Immediate-Release Drugs

US FDA is moving forward on two fronts to update and improve the Risk Evaluation & Mitigation Strategy to help limit misuse and abuse of opioid pain medications: the agency has a plan to incorporate IR sponsors into the existing REMS, and also a new 'blueprint' for the prescriber education that focuses on pain management.

Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations

Agency has been hesitant to take the steps because of logistical difficulties of creating an enormous program, but has been pushed by its risk management advisory committee, among others.

Opioid Approval Standards Not Up For Debate, FDA Tells Advisory Cmte.

As Egalet's Arymo ER heads to panel, agency tries to head off discussion about whether it should be approving new opioid products and whether longer clinical efficacy trials should be demanded.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS079476

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