Announcing recent updates to the REMS Web site and SPL initiatives

We are excited to announce updates to the REMS Web site and Structured Product Labeling (SPL) initiatives. The updates are a result of feedback received from stakeholders, who asked that the agency provide information on REMS programs in a more direct and user friendly format. Please feel free to provide comments or ask questions on this contact us form.

Version 2.0 of REMS@FDA

On July 25, FDA launched version 2.0 of the Risk Evaluation and Mitigation Strategies (REMS) Web site,REMS@FDA. This update is designed to improve the usability of the site and to provide more information on each REMS-specific webpages, including:

• Adding The REMS goals.
• Adding a brief description of changes made to REMS when they are updated.
• Embedding links to the associated REMS materials in the Summary requirement.

In addition, the website provides the latest count of the number of current REMS and a report of released REMS on this webpage. 

First REMS SPL submission

The first REMS SPL submission is now available is now available on DailyMed in the REMS & REMS Indexing Files. 

SPL is a data standard for capturing information about drug products, including labeling, registration and listing, and now REMS. SPL information is easily shared and can be readily incorporated in to healthcare information technology. Health IT vendors will now have the opportunity to leverage SPL data to provide REMS information within health systems.