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 Risk Management: FDA Not Impressed With Industry Working Group's Proposals

This article was originally published in The Pink Sheet Daily

Executive Summary

After a meeting that produced little aside from a suggestion that DEA may be able to track physician training, has industry lost its chance to craft a REMS for the pain products?

You may also be interested in...



FDA Finalizing Opioid REMS Proposal, Sets Joint Advisory Committee Meeting For July

FDA wants to gather feedback from advisors and from the public on the classwide REMS for opioid analgesics, and judging from the stakeholder meetings the agency has held so far, it will get an earful.

FDA Finalizing Opioid REMS Proposal, Sets Joint Advisory Committee Meeting For July

FDA wants to gather feedback from advisors and from the public on the classwide REMS for opioid analgesics, and judging from the stakeholder meetings the agency has held so far, it will get an earful.

Acurox Panel Review Complicated By FDA's Uncertainty Over How Much Evidence Is Needed To Prove Abuse Deterrence

FDA is not convinced that additives meant to make the immediate-release oxycodone formulation difficult to ingest, snort or inject will have their intended deterrent effect.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068942

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