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

FDA's Opioid Policy Reboot: New Risk-Benefit Model, Real-World Data

This article was originally published in The Pink Sheet Daily

Executive Summary

Science Board also suggests ways to improve REMS-mandated prescriber education.

You may also be interested in...



Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 14.

The Politics Of Opana: US FDA’s Opioid Problems Won’t Go Away

A two-day safety review of Endo’s reformulated Opana ER provided strong support for FDA’s view that products using abuse-deterrent technology cannot simply be assumed to be 'safer' than conventional formulations. However, there are also no easy answers for when and how FDA will be able to move out of the hot seat on opioid abuse.

Pfizer’s Troxyca And The Limits Of Advisory Committee Review For Opioids

FDA approved Pfizer’s oxycodone/naltrexone extended release opioid with abuse deterrent claims similar to Embeda. That isn’t the label FDA’s advisory committee supported.

Topics

Related Companies

UsernamePublicRestriction

Register

PS079277

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