REMS
Effort Underway to Improve Standards for REMS Adjudication
The REMS for certain high-risk medications can be cumbersome and time-intensive, with manual entry requirements ...
DECEMBER 6, 2024
FDA Determines REMS for Alosetron No Longer Necessary
The FDA has determined Risk Evaluation and Mitigation Strategies for the irritable bowel syndrome drug alosetron ...
SEPTEMBER 26, 2023
FDA Mulls New Mail-Back Approach for Unused Opioids
The FDA is seeking public comment on potential changes to the existing opioid REMS to include a postage–paid, ...
MAY 24, 2022
FDA Report About Discussing REMS With Patients Available
A new FDA report outlines best practices for counseling when discussing drugs with REMS.
SEPTEMBER 29, 2017
REMS Programs Help FDA, Stakeholders Work Together to Enhance Drug Safety
The FDA makes every effort to make REMS requirements as least burdensome as possible. Our goal is to maintain ...
MARCH 10, 2017
