REMS News, Education, Meetings and Improvement Efforts
The REMS Integration Initiative
FDA established the Risk Evaluation and Mitigation Strategies (REMS) Integration Initiative to evaluate and improve the implementation of its REMS authorities. The goals of the REMS Integration Initiative include:
- Developing guidance on how to apply the statutory criteria to determine when a REMS is required,
- Improved standardization and assessment of REMS, and
- Improved integration of REMS into the existing and evolving healthcare system.
This initiative incorporated input from stakeholders on issues and challenges associated with the development, implementation and assessment of REMS.
The following is information related to the work of the REMS Integration Initiative:
- REMS Standardization Initiatives/REMS Integration Initiative: REMS Integration Initiative Aims to Standardize REMS and Encourage Better Integration into the Health Care System
- Includes links to REMS@FDA and October 2015 REMS Public Meeting website
- REMS Integration Initiative
- Includes links to several different public and Brookings meetings as well a link to the REMS Standardization Report, approved REMS, SPL webinar and SPL FRN, REMS platform presentations
- Includes report on REMS and Continuing Education for Health Care Providers: FDA Feasibility Report (PDF - 228KB)
- Includes report on A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS (PDF - 558KB)
- Standardizing and Evaluating Risk Evaluation and Mitigation Strategies: Report Sept, 2014
REMS Education
- CDER SBIA Webinar: Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive-June 15, 2017
- FDA Basics Webinar: A Brief Overview of Risk Evaluation and Mitigation Strategies (REMS)
- CDER SBIA Webinar: Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry - April 7, 2015
- Risk Evaluation and Mitigation Strategies (REMS) Drug Info Rounds Video
Public and Expert Meetings on REMS
- Risk Evaluation and Mitigation Strategies Public Meeting 2010
- Standardization and Evaluation Public Meeting 2013
- REMS Integration Initiative Aims to Standardize REMS and Encourage Better Integration into the Health Care System 2015
- Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge Public Meeting 2012
- Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access 2015
- Incorporating continuing education into single-drug REMS: Exploring challenges and opportunities May, 2015
- Risk evaluation and mitigation strategies (REMS): Building a framework for effective patient counseling on medication risks and benefits July, 2015
- Risk Evaluation and Mitigation Strategies: Improving Benefit-Risk Counseling Between Providers and Patients Expert Workshop April, 2016
- Building a Common Risk Evaluation and Mitigation Strategies Platform June, 2016
Other REMS News and Reports
- Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
- REMS and Continuing Education for Health Care Providers: FDA Feasibility Report: This assessment discusses potential scenarios for incorporation of continuing education into REMS.
- Framework for Benefit-Risk Counseling of Patients Taking Drugs with REMS. This report is designed to support health care providers who are counseling patients about drugs that require a REMS.
- OIG Report: FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety.
Archived information
- Identification of Drug and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies Federal Register Notice (3/27/2009)
- Risk Evaluation and Mitigation Strategies (REMS) Letters to Sponsor/Applicants Requesting Labeling Changes [ARCHIVED]
Current REMS
FDA maintains a website listing medications with approved REMS that are currently active and their associated materials, at (REMS@FDA).