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's Opioid REMS Review Puts Brakes On Mandatory Education Push

This article was originally published in The Pink Sheet Daily

Executive Summary

Requiring training and certification for extended-release opioids would involve at least 320,000 prescribers and impact 21 million outpatient prescriptions, reviewers note in a briefing memo that is more skeptical of the mandatory approach than FDA's leadership has been.

You may also be interested in...



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.

Restrictive REMS Is Least Favored Path For Opioid Prescriber Education

FDA advisory committee's preferred approaches – linking mandatory training to DEA registration or state medical board licensing – are outside agency's existing regulatory authority.

Opioid REMS Prescriber Education Should Be Mandatory, FDA Panel Says

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

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079350

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