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

Shared REMS For Transmucosal Fentanyls Could Expand Market For Meda’s Onsolis As It Exits More Restrictive Program

This article was originally published in The Pink Sheet Daily

Executive Summary

Class-wide Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products will begin operations in March 2012, with participants in REMS for individual products to be transitioned automatically to the new system.

You may also be interested in...



Coming Soon: New US FDA Opioid Plan

Commissioner Robert Califf said the new plan should be released in August and include prongs to continue fighting the ongoing prescription opioid epidemic, as well as confront a new synthetic fentanyl and methamphetamine problem.

Keeping Track: Neurology And Pain Products Keep FDA Occupied

The latest drug development news and highlights from our FDA Performance Tracker.

Stairway To Heaven: REMS Website Integrated With Health Care Systems

Participants in a two-day FDA meeting on REMS standardization and assessment suggested a website containing all REMS information and enrollment functions and allowing interaction with existing health records and claims systems would facilitate compliance with safety requirements.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS073207

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