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

Opioid Bills Could Enhance US FDA Approval, Withdrawal Authority

Executive Summary

House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.

You may also be interested in...



Opioid Approvals: Congress Wants US FDA Guidance On Abuse Potential

Instead of creating new mandate, legislation tells FDA to outline how risk-benefit decisions could be influenced by a product's abuse potential under existing approval authority; final opioids package expected to reach the White House soon.

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

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."

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123896

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