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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
04/13/2017
12/31/2013 Modified to eliminate the requirement for the Medication Guide and the communication plan as elements of the REMS.
03/27/2013 Modified to remove the requirement of prescriber and hospital re-enrollment every three years in the ESA APPRISE Oncology Program.
05/31/2012 Modified to incorporate the name and logo change of the marketer and distributor of Procrit from Centocor Ortho Biotech to Janssen Products, LP in the REMS document and the ESA APPRISE Oncology Program REMS materials, including the REMS website.
06/24/2011 Modified to provide consistency with the revised package insert and to revise the REMS document and the ESA APPRISE Oncology Program REMS materials, including the REMS website, to facilitate implementation of the program and to more concisely and effectively present important information.
02/16/2010 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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