Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

US FDA To Withdraw Pain Drug Guidance As Part Of Response To Opioid Epidemic

Executive Summary

"At least four" guidances will replace it, Commissioner Gottlieb notes in frank update which states "I don’t want to look back ten years from now and wish there were more policies we had pursued, or more steps we had taken, to stop the advance of this crisis."

You may also be interested in...



Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected

In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.

US FDA Faced With Suite Of Opinions Defining 'Clinically Meaningful' Opioid-Sparing Claims

Advisory committee agreed that statistically significant reduction in average opioid use and decrease in absolute amount were insufficient components on their own; a decrease in duration of use and a decrease in the amount of patients who don't need opioids received some support.

Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse

The Australian drug regulator is reviewing the indications, pack sizes and information documents for consumers of potent opioid products to see how misuse and overdoses can be prevented.

Related Content

Topics

UsernamePublicRestriction

Register

PS123774

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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