REMS Integration Initiative
In 2011, FDA launched the REMS Integration Initiative with the goal of evaluating and improving our implementation of Risk Evaluation and Mitigation Strategies (REMS) authorities. The REMS Integration Initiative was built on stakeholder feedback including at least 3 public meetings, 5 workshops, 15 listening sessions, and a pilot with 9 REMS application holders. FDA also engaged outside entities, including think-tanks and standards development organizations to ensure comprehensive stakeholder representation. (A discussion of some of the issues identified and addressed during this initiative can be found here.)
Most of the activities completed under the REMS integration initiative were chosen to address specific stakeholder concerns. FDA published 5 guidances (listed below) to address topics including the determination of when a REMS is necessary, format of REMS documents, and tools for electronic submission. FDA also published 3 reports (also listed below) describing targeted projects to address specific stakeholder concerns, including building the REMS@FDA website. A webinar describing work completed under this initiative can be found here.
The REMS Integration Initiative ended in October 2017, but efforts to evaluate and advance the REMS program endure. The REMS Platform Standards Initiative is just one example of an ongoing project to continue improving REMS; a key part of FDA’s mission to make safe and effective therapies available, and to always protect and promote the public health.
Guidances
- Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry
- Format and Content of a REMS Document Guidance for Industry
- Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
- FDAâs Application of Statutory Factors in Determining When a REMS Is Necessary
- Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
Reports
- REMS and Continuing Education for Health Care Providers: FDA Feasibility Report
- A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS
- Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)
Webinars
- December 4th 2017 CDER SBIA Webinar: REMS Integration Initiative Overview (Presentation)
- December 4th 2017 CDER SBIA Webinar: REMS Integration Initiative Overview (Slides)
- June 15th 2017 CDER SBIA Webinar: REMS SPL Update (Presentation)
- June 15th 2017 CDER SBIA Webinar: REMS SPL Update (Slides)
- August 24th 2016 CDER SBIA Webinar: Introduction to REMS SPL (Presentation)
- August 24th 2016 CDER SBIA Webinar: Introduction to REMS SPL (Slides)
Meeting Information
- April 14, 2016 Duke Expert Workshop: REMS Patient Counseling - Meeting Information
- October 5-6 2015: Understanding and Evaluating REMS Impact on the Healthcare Delivery System and Patient Access
- July 24, 2015 Brookings Expert Workshop: REMS Patient Counseling � Meeting Information
- May 18, 2015 Brookings Expert Workshop: REMS Continuing Education � Meeting Information
- July 25-26, 2013 Standardizing and Evaluating REMS â Meeting Information
- March 8, 2013 REMS Update for PDUFA Stakeholders - Meeting Minutes
- March 8, 2013 REMS Update for PDUFA Stakeholders - Slides
- June 7, 2012 Public Workshop on REMS Assessments: Social Science Methodologies to Assess Goals Related to Knowledge
Related Resources
- 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
- FDA Voice Blog: FDA Is Making It Easier To Meet Required Extra Safety Measures for Certain FDA-Approved Drugs
- Approved Risk Evaluation and Mitigation Strategies (REMS)
- REMS SPL Pilot - Materials
REMS Platform Standards Initiative
- REMS Platform Standards Initiative: Needs Assessment
- June 7, 2016 Duke Public Workshop: Building a Common REMS Platform
- October 5, 2016 Common REMS Platform Presentation
- Sign up for Common REMS Platform Alerts