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
UsernamePublicRestriction

Keep Limits On Off-Label Promotion, Consumers And Patients Say

Executive Summary

Prescribers can get information they need through continuing education programs and scientific conferences, non-industry stakeholders tell US FDA during second day of meeting on manufacturer communications for unapproved uses.

You may also be interested in...



Off-Label Wish List: Industry Groups Want US FDA's Guidances To Do More

Sponsors and payers question guidances' scope and potential audiences, and wonder if the agency couldn't just perform some retrospective audits of off-label communication to speed things up.

Off-Label Promotion: 'Safe Harbor' Preferable To Expansive Free Speech Rulings

Payer- and physician-directed communications would be best addressed through a regulatory 'safe harbor' rather than First Amendment challenges where the outcome might sweep up consumer-directed communications, lawyers say at FDA/CMS Summit.

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

Related Content

Topics

UsernamePublicRestriction

Register

ID1128360

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

Cancel