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?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
| Assessment Plan |
|---|
| 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 |
|---|---|
| 06/30/2022 | Modified to deactivate the PS-Lenalidomide Shared System REMS and join the Lenalidomide Shared System REMS. |
| 10/14/2021 | Approval of 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.