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

Patient Testimony Highlights Difficulties Of Pain Drug Development, US FDA Regulation Of Opioids

Executive Summary

At patient-focused drug development meeting, many patients explained that opioids gave them functionality versus side effects such as suicidal ideation and fatigue that come with other treatments.

You may also be interested in...



Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the 

Opioid Policy At US FDA: Over-Promising Or Overreacting?

As President Trump signs SUPPORT Act, former FDA chief counsels offer dueling interpretations of agency's impact in combating opioid crisis.

Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns

US FDA's education blueprint now asks sponsors to extend REMS to health providers beyond prescriber, but pain classifications remain unchanged.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123459

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