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USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released draft guidance "REMS Logic Model: A Framework to Link Program Design With Assessment" last Thursday (07 May 2024) for comments.


REMS (risk evaluation and mitigation strategy): A REMS is a drug safety program that the Food and Drug Administration can require for certain drugs with serious risks to help ensure the benefits of the drug outweigh its risks as outlined in sections 505-1 of the Federal Food, Drug, and Cosmetic Act.


REMS logic model: Program logic model with assumptions built on the theory of change that provides a systematic approach for the design, implementation, and evaluation of a REMS.


Risk Evaluation and Mitigation Strategies (REMS) are required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of certain medications outweigh their risks. REMS are safety strategies required for certain medications to manage known or potential risks. The REMS Logic Model is a framework that helps stakeholders design and assess REMS programs effectively.


The guidance describes FDA’s risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which 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 applicants of new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) 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.


FDA’s REMS logic model provides a recommended framework to help applicants design, implement, and evaluate a REMS. Although the REMS logic model appears linear, it is a process in which steps are moved back and forth or toggled between to address uncertainties, validate assumptions, incorporate new information, and refine the REMS program. As a result of toggling, a REMS can be continually verified in terms of the relationship between its objectives, strategies, and intended outcomes.


Check out this guidance for more detailed information on the considerations for applying a logical model.

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