REMS Platform Standards Initiative: Needs Assessment

REMS Platform Standards Initiative: Needs Assessment

Introducing the REMS Platform Standards Initiative Needs Assessment

We are pleased to announce the posting of the “REMS Platform Standards Initiative Needs Assessment” on our REMS Integration Initiative Website.  This document is designed to provide specific, detailed information on the areas in which electronic data standards development is needed and the information that these standards would need to communicate. The document builds on the discussions from the June 2016 Duke-Margolis Public Meeting “Building a Common REMS Platform”, in which FDA obtained feedback on approaches to developing electronic data standards that REMS could use to operate within the healthcare system and communicate with participants in a standardized way. 

This needs assessment is part of FDA’s broader REMS Platform Standards Initiative.  This initiative is intended to encourage and support the development of data standards, called REMS platform standards, to help standardize REMS with elements to assure safe use and better integrate them into the increasingly electronic health care system.

Thank you for your interest in the REMS Platform Standards Initiative, and please don’t hesitate to contact us at REMS_Standardization@fda.hhs.gov if you have any questions.

The REMS Integration Initiative Web Page