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

Opioid Indications Under TGA Scrutiny As Australia Tackles Growing Misuse

Executive Summary

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.

You may also be interested in...



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

"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."

Eradicating ‘Indication Creep’ One Of Eight Australian Proposals To Tackle Opioid Misuse

Australian regulators are proposing to review the indications of strong opioids to see if they are appropriate, according to one of eight regulatory options for addressing the growing problem of opioid misuse in the country.

EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications

Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123872

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