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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
04/02/2025
12/12/2024 Modified to update the REMS Website to add functionality to the pharmacy portal to add previously removed users back to the system, the ability to view past REMS Dispense Authorizations (RDAs) for a patient, and the ability to reverse an RDA via the portal.
05/17/2024 Revised to make editorial updates to replace a trademark symbol and re-addition of "Shared System" in the title of the REMS Document.
03/22/2024 Modified to:
  1. Add Opsynvi (macitentan and tadalafil) product information
  2. Change the name of the REMS to Macitentan-Containing Products REMS
  3. Allow for greater than 30-days’ supply when initiating Opsynvi in patients who are treatment naïve or those transitioning from endothelium receptor antagonist (ERA) monotherapy
  4. Add information on “Office Contacts” and their role in assisting prescribers with the REMS
  5. Clarify the certification requirements of the outpatient pharmacy
02/01/2023 Modified to:
  1. Streamline the REMS by removing redundancies and unnecessary features including the Patient Enrollment Form – For VA Use Only, Patient Pre-Enrollment functionality, Patient Portal, and patient’s ability to initiate Prescriber Transfer.
  2. Change the outpatient pharmacy certification and REMS Dispensing Authorization (RDA) processes to ensure REMS requirements are met prior to dispensing.
  3. Update the Prescriber and Pharmacy Guide to include additional instructions for pharmacies to provide reasons for dispensing a greater than 30 days’ for a female of reproductive potential and to provide reasons for treatment interruption.
  4. Update the REMS assessment timetable.
  5. Update the REMS website URL and website functionality to remove duplicate screens and to align with updated processes.
04/06/2021 Approval of the 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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