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


Off-Label Communication Growth: Could FDA Afford To Police It?

Executive Summary

Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.


Related Content

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy
Payers Want Access To US FDA's Pre-Submission Meetings
Keep Limits On Off-Label Promotion, Consumers And Patients Say
‘Who Is The Arbiter?’ US FDA Asks As It Mulls Loosening Off-Label Reins
Off-Label Communications: Industry, FDA Debate Role Of Peer Review
FDA's Off-Label Communication Changes Should Start With Payers – PhRMA
Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program
FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders
Congressional ‘Cures’ Debate Shifts To FDA Funding
DTC User Fees Shot Down; Advertisers Face More Perilous Future





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