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

New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics

Executive Summary

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

You may also be interested in...



New Opioid Labeling Further Constrains Use, Urges Prescribing Only By Docs ‘Knowledgeable’ About Risks

US FDA’s mandated labeling changes come after the agency required manufacturers to provide mail-back envelopes for opioid disposal.

Califf Hints At Labeling Changes For Opioids And Chronic Pain

Califf also said the agency is open to endpoints other than abstinence for new opioid use disorder treatments at the fourth annual NIH HEAL Initiative Investigator Meeting. 

Califf Urges Congressional Patience On Opioid Actions

Labeling changes for the pain products remain in active discussion, the US FDA commissioner tells the Senate Health, Education, Labor and Pensions Committee during a hearing on the monkeypox outbreak.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146966

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