Medtech Insight 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

FDA Memo Reiterates Off-Label Enforcement Policy

Executive Summary

Pre-Trump agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.

Advertisement

Related Content

Unlocking Legalities: Overseas Practices, Park Doctrine Could Drive More Fraud Cases
FDA Cracks Open Door For More Manufacturer Communications
US FDA Clarifies ‘Intended Use’ Policy For Approved Products
US FDA Hears Competing Messages On Off-Label Communications
Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register