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 Opioid REMS Proposal Leaves Advisory Panel Wanting More - i.e. Mandatory Training

This article was originally published in The Pink Sheet Daily

Executive Summary

Prior training programs have been much smaller in scope, OND Director John Jenkins points out.

You may also be interested in...



Mandatory Prescriber Education For Opioids; Is This The Time?

US FDA is once again asking whether its opioid Risk Evaluation & Mitigation Strategy program for opioids should make continuing education requirements mandatory for prescribers. This time there may be no choice but to move forward with the plan.

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.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS070950

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