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 CME Expectations For Opioid Prescribers Keep Sponsors At A Distance

Executive Summary

Manufacturers of long-acting/extended-release opioids must develop a blueprint for physician education in pain management with their products, but otherwise will be involved only at arms’ length in the doctor training portion of the Risk Evaluation and Mitigation Strategies.

You may also be interested in...



Opioid Physician Training Options Remain Limited After Initial Launch

FDA encourages physicians to take advantage of an educational program funded by sponsors of the analgesics as part of the REMS for extended-release opioid products, but only three programs were identified by the March 1 launch date, with Boston University taking the lead.

Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint

Prescriber training courses to be provided through continuing medical education venues are to be available by March 1, 2013. Changes from the draft are subtle, but indicate FDA’s focus on preventing incorrect use of the high-dosage narcotics and protecting patients.

Opioid REMS Requires Sponsors To Launch Prescriber Training CME Within 9 Months

By the third year of continuing medical education efforts, FDA expects 60% of those who wrote a prescription for a long-acting/extended-release opioid in 2011 to receive training.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053669

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