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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
09/08/2023
05/18/2022 Revised to reflect editorial changes.
05/05/2022 Modified to make changes to the Prescriber Education Slide Deck to align with the REMS modification approved October 18, 2021 and add a link on the REMS website to the “Letter for Healthcare Providers” and to update the Terms of Use page version and date information.
10/18/2021

Modified to:

  1. Update the REMS Letter to Healthcare Providers to remove information related to program changes that were made in 2016, as that information is no longer relevant to prescribers becoming newly trained
  2. Make changes to the REMS call center hours
  3. Remove the option for prescribers to mail the Prescriber Completion of Training Form
08/05/2019 Revised website screenshots to remove individual applicant names.
11/22/2016 Modified to reflect the inclusion of an additional ANDA into the alosetron 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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