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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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

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
03/22/2024
08/03/2022 Revised to reflect editorial change.
07/22/2022 Modified to change the REMS document to align with labeling and updated REMS materials to incorporate the revised logo capturing both intravenous and subcutaneous routes of administration.
04/27/2022 Modified to revise Prescriber Safety Brochure to include the indication for generalized myasthenia gravis. In addition, changes to all educational REMS materials were made to align with labeling.
11/23/2021 Modified to:
  1. Update the Prescriber Enrollment Form to remove the “Other (please specify):” from the Credentials Box and a change in font color from orange to blue to highlight the website address and email address.
  2. Change the Prescriber Safety Brochure to update the indication sentence for PNH to include pediatric (one month and older) patients.
  3. Update the copyright date on all REMS materials.
04/30/2020 Modified to make changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form from two pages to one page.
10/18/2019 Modified to reflect changes to the Prescriber Safety Brochure including adding the new indication.
12/21/2018 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.

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