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

REMS Assessments For Opioids Will Require Data From Across Health System

Executive Summary

Measuring success will be one of the thorniest issues confronting sponsors as they implement the FDA-mandated Risk Evaluation and Mitigation Strategy for long-acting/extended-release opioids.

You may also be interested in...



Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment

REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.

Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing

All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.

Opioid Class-Wide REMS May Launch Without Element To Monitor Prescribing

All metrics for assessing the effectiveness of the Risk Evaluation and Mitigation Strategy for long-acting/extended release opioids may not be in place when FDA approves REMS for individual products.

Related Content

Topics

UsernamePublicRestriction

Register

PS053334

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