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

FDA's Opioid Action Plan Could Clear Califf Nomination Roadblock

This article was originally published in The Pink Sheet Daily

Executive Summary

Policy shifts to address opioid abuse epidemic include changes to immediate-release opioid labeling, updated REMS requirements, and a new advisory committee.

You may also be interested in...



New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics

US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.

Opioid Approval Standards Could Change Under New US FDA Plan

The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.

US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews

Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS079175

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