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

Opioid Policy At US FDA: Gottlieb Seeks More Activist Role To Combat Abuse

Executive Summary

‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.

You may also be interested in...



‘Abuse-Deterrent’ Opioids May Be Headed For A Terminology Change

US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.

Drug Development Questions Dominate Hahn's Confirmation, Despite Talk About E-Cigs

A plurality of the questions from the Senate HELP Committee at Stephen Hahn's confirmation hearing to head the US FDA focused on drug development issues, despite the time lawmakers spent discussing the agency's regulation of e-cigarettes.

Curtain Falls On Opana ER As Endo Agrees To US FDA Withdrawal Request

Company will cease manufacturing the extended-release oxymorphone formulation immediately and will not ship existing finished product after Sept. 1; decision to pull the opioid from the market heads off a fight with FDA, which sought withdrawal due intravenous abuse liability.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120388

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