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 Guidance Is Silent On Generics, Cautions That Addicts Can Erase Labeling

This article was originally published in The Pink Sheet Daily

Executive Summary

Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.

You may also be interested in...



Opioids: FDA Asks If Abuse-Deterrence Incentives Are In Line

Agency chief counsel says exclusivity for better formulations may need to be considered.

Abuse-Deterrent Opioids Could Gain Significant First-Mover Advantage Under FDA Guidance

FDA recommends head-to-head studies against already marketed products – an unusual development policy for the agency.

Opioid Abuse Deterrence: FDA Development Ideas Are Out Of This World

To stimulate new ideas for better formulations, outgoing FDA commissioner Hamburg consulted X Prize Foundation about innovation competition.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074871

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