Pink Sheet is part of the Business Intelligence Division 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
UsernamePublicRestriction

REMS Assessment Challenges Shine Through In Opioids Review

Executive Summary

Longitudinal studies and possibly a randomized, controlled trial are needed, FDA's advisory committee says; panelists were underwhelmed by product sponsors' survey, surveillance and drug utilization data.

Advertisement

Related Content

FDA Expanding Opioid REMS To Immediate Release Formulations
Postmarketing Studies On Abuse-Deterrent Opioids Could Get New Look
Opana ER Panel Urged To Disregard ‘Invalid’ Human Abuse Liability Study
FDA New Year’s Resolution: Guidances On Payor Communications, Biosimilarity
Restrictive REMS Is Least Favored Path For Opioid Prescriber Education

Topics

Advertisement
UsernamePublicRestriction

Register

PS057637

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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