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 Opioid Review Adds Another Push For Advisory Committee Overhaul

Executive Summary

External report on the US FDA’s response to the opioid epidemic includes detailed recommendations for enhancements to the advisory committee review process. That dovetails with the agency’s ongoing look at how best to use the expert panels.

You may also be interested in...



US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time

FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.

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.

Califf And Advisory Committees: Will He Push For Reforms?

Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147839

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