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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
06/13/2025
09/29/2023 Updates to reflect a change in application ownership
11/10/2021 Modified to make changes to the hours of operations for the Clozapine REMS Contact Center.
07/29/2021 Modified to:
  1. make changes to the frequency of the submission of patient monitoring via a new Patient Status Form and make changes to the pharmacy operations to verify safe use conditions for a REMS dispense authorization
  2. revise the third goal to read from "ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine" to "ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia"
02/18/2021 Modified to:
  1. remove reference to Fazaclo (clozapine) and Jazz Pharmaceuticals Inc. from the following materials:
    1. Clozapine and Risk of Neutropenia: A Guide for Healthcare Providers
    2. Clozapine REMS Website
  2. add a previously approved generic formulation for orally disintegrating tablet produced by Teva (ANDA203039) to the generic products table on the REMS website
11/12/2019 Revised to reflect editorial changes.
01/16/2019 Modified to incorporate the addition of educational materials, changes to the inpatient prescriber certification requirements and patient monitoring, and initiating the operational restrictions for prescriber and pharmacy certification.
09/15/2015 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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