> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on How to Develop REMS Shared System
- URL: https://www.fdaweb.com/guide-on-how-to-develop-rems-shared-system/
- Published: 2018-06-01T12:00:00.000Z
- Updated: 2026-09-15T00:09:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141581

*Federal Register* notice: FDA has made available a draft guidance entitled “Development of a Shared System REMS.” The document provides recommendations on developing a risk evaluation and mitigation strategy shared system for multiple prescription drug (including biological) products. It also describes some of the possible benefits of a shared system, and provides general principles and recommendations to assist industry with developing these programs. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-01/pdf/2018-11783.pdf?ref=fdaweb.com).