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

Providers Still See Drawbacks To Opioid Education Mandates

Executive Summary

Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.

You may also be interested in...



FDA Exploring Partnerships As Alternative To REMS Mandate For Opioid Education

The US FDA is continuing to think through mechanisms to make opioid prescriber education mandatory – either separate from or in addition to relying on its REMS authority. 

Non-Opioid Pain Treatments Likely Not Eligible For Accelerated Approval, US FDA Says

Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.

Califf Confirmation Hearing Round Two: Industry Ties Once Again May Bark Loud, Bite Lightly

The cardiologist seeking another term as FDA commissioner has been working in the pharma industry since leaving the post, but Senators have tended not to  question nominee's work history extensively during previous confirmation hearings.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145219

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