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# Draft Guide on REMS Shared System Waivers
- URL: https://www.fdaweb.com/draft-guide-on-rems-shared-system-waivers/
- Published: 2018-06-01T12:00:00.000Z
- Updated: 2026-09-15T00:09:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141582

*Federal Register* notice: FDA is making available a draft guidance entitled “Waivers of the Single, Shared System REMS Requirement.” The document describes how FDA intends to consider granting a waiver on the requirement that an ANDA applicant and reference-listed drug maker use a single, shared system for a required risk evaluation and mitigation strategy that contains elements to assure safe use. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-06-01/pdf/2018-11784.pdf?ref=fdaweb.com).