Pink Sheet is part of the Business Intelligence Division 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


Buprenorphine Waiver Sheds Little Light On FDA Decision-Making Process

Executive Summary

But the agency appeared willing to consider a waiver because the innovator and generic sponsors could not reach agreement on a shared REMS.


Related Content

REMS “Abuses” Concern FDA, But Can Scolding Help Speed Generic Entry?
REMS Modification Guidance Coming As FDA Rejects Petition For Shared REMS Rules
Shared REMS Systems Show Challenges Of Standardization – Could PDUFA V Help?
A Look At The First Six Shared REMS


Related Companies




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