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 Will Require Class-Wide REMS For Opioids; “Massive” Program Compared To Past Efforts

This article was originally published in The Pink Sheet Daily

Executive Summary

Class-wide REMS will encompass 24 marketed products from 16 different manufacturers; focus on extended-release products.

You may also be interested in...



Opioid Approval Delay? Class REMS Poses Legal Questions For Pending Drugs, FDA Says

Office of New Drugs Director John Jenkins explains the agency’s options in approving pending potent opioids in lieu of a class-wide REMS.

Opioid Approval Delay? Class REMS Poses Legal Questions For Pending Drugs, FDA Says

Office of New Drugs Director John Jenkins explains the agency’s options in approving pending potent opioids in lieu of a class-wide REMS.

Class-Wide REMS For Opioids: A Look At The Products Affected

Class-Wide REMS For Opioids

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS069092

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