In Vivo 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

UsernamePublicRestriction
UsernamePublicRestriction

MedGuide=REMS? Not Always

This article was originally published in RPM Report

Executive Summary

FDA and stakeholders agree that MedGuide-only REMS are more trouble than they are worth. The agency has already told two sponsors that they don't need a REMS even though they need a MedGuide--but only because there are other products in the class that don't have REMS.
Advertisement

Related Content

REMS 2.0: FDA Refining New Drug Safety Tools
REMS 2.0: FDA Refining New Drug Safety Tools
Cymbalta for Fibromyalgia: The REMS That Wasn't
The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS080761

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