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


FDAAA Impact Analysis (Year 3): REMS R.I.P.? Not Yet

This article was originally published in RPM Report

Executive Summary

FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.

Related Content

FDAAA Impact Analysis (Year 4): The REMS Retreat Continues, But For How Long?
REMS 2.0: FDA Refining New Drug Safety Tools
FDAAA Impact (Year Two): More of Everything
Waking Up to REMS (Part 3): Redefining Marketing
The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two
Waking Up to REMS (Part 2): What You Don't Know Can Hurt You
Waking Up to REMS (Part 1): Don't Believe the Lack of Hype
FDAAA Impact Analysis: Year One
The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools
FDAAA Pays Off: Drug Safety Controls Bring Immediate Returns to Sponsors





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