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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
04/04/2025
09/11/2024 Revised to make editorial changes
08/19/2024 Modified to:
  1. Change the timetable for submission of assessments to September 28, 2024 and annually thereafter.
  2. Update the REMS Document formatting to include the risk of embryofetal toxicity in the Administrative Information section and adding section VI for Statutory Elements.
  3. Update pharmacy requirements in the REMS Document and Outpatient Pharmacy Enrollment Form to align with REMS operations. Additional updates clarify the Role of Certified Pharmacies in the Prescriber and Pharmacy Guide and REMS Website.
06/08/2021 Modified to:
  1. Remove the pop-up on the Ambrisentan REMS website home page.
  2. Align the inpatient and outpatient pharmacy requirements within the Prescriber and Pharmacy guide and the REMS website with the REMS document.
  3. Remove the term "for approval" from the Outpatient Pharmacy requirement regarding the authorization to dispense a greater than 30-day supply in the Prescriber and Pharmacy Guide and REMS Website.
12/22/2020 Modified the Prescriber and Pharmacy Guide and on the REMS website changes were made to: Clarify inpatient pharmacy requirements for when an enrolled patient is continuing ambrisentan in the inpatient setting and is already under the supervision and care of a certified prescriber to align with the existing inpatient pharmacy requirements in the approved REMS document. Include a provision for prescribers to authorize a greater than 30-day supply for females of reproductive potential due to travel or personal extenuating circumstances at the prescriber’s medical discretion. Addition of certified outpatient pharmacy listings and links to Spanish language REMS materials on the REMS website. A new office contact portal.
03/28/2019 Approval of Shared System 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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