Approved Risk Evaluation and Mitigation Strategies (REMS)
Shared System REMS
REMS last update:
What is the purpose of the REMS?
What do participants need to know?
| Assessment Plan |
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This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available. |
What updates have been made to the REMS?
| Date | Summary of change |
|---|---|
| 05/06/2021 | |
| 06/07/2019 | Modified to update the language in the Dear Healthcare Provider letter to remove the terms “new,” “recent,” and “now,” when discussing safety information that was added in 2015, and to change the signatory on the letter. |
| 05/17/2016 | Modified to clarify the implementation date of the communication plan and the timetable for submission of assessments of the REMS. |
| 12/08/2015 | Modified to change the REMS appended materials including the "Key Techniques to Reduce Injection Site Reactions" Poster, and the Dear Healthcare Provider Letter. |
| 07/29/2013 | Modified to revise the Medication Guide, add a communication plan to include information about the serious risks associated with Vivitrol (naltrexone for extended-release injectable suspension), and a revise the timetable for submission of REMS assessments. |
| 10/12/2010 | Modified to add information about the risks associated with the use of Vivitrol for the treatment of opioid dependence in the Medication Guide. |
| 03/22/2010 | Approval of the REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.