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 Suspends Some Clozapine REMS Program Requirements
On July 29, the FDA approved a modification to the Clozapine REMS program, which was to begin on Nov. 15. However, ...
NOVEMBER 23, 2021
Zulresso Approved to Treat Postpartum Depression
The IV medication carries a boxed warning and will be available only through the Zulresso REMS Program, which ...
MARCH 21, 2019
FDA to Widen Opioid REMS to IR Formulations
The FDA will broaden the existing opioid REMS, which currently only covers extended-release, long-acting ...
OCTOBER 5, 2017
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
