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FDA Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry (Catapult’s regulatory round-up – May 2024)

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.

While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS. FDA can require a REMS before initial approval of a new drug or after the drug has been approved should FDA become aware of new safety information about a drug and determine that a REMS is necessary to ensure that the benefits of the drug outweigh its risks.

The purpose of this draft guidance is to describe the FDA’s REMS logic model which is a framework that provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. Comments can be submitted until 6 August 2024.

Published on the 5th of June in Catapult’s regulatory round-up for May 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (4 novembre 2024). FDA Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance for Industry (Catapult’s regulatory round-up – May 2024). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/12m78


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