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# Guide on REMS Logic Model
- URL: https://www.fdaweb.com/guide-on-rems-logic-model/
- Published: 2024-05-07T12:00:00.000Z
- Updated: 2026-09-14T14:30:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156936

*Federal Register* notice: FDA is making available a draft guidance entitled “REMS Logic Model: A Framework to Link Program Design With Assessment.” The document describes the logic model as a recommended framework that provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help product applicants incorporate REMS assessment planning into the design of a REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-05-07/pdf/2024-09928.pdf?ref=fdaweb.com).