Jill Kolesar & Lee Vermeulen

Professors, University of Kentucky

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Replying to Ngan Hoang

It would be great if someone can help me to understand what is REMS program.
Thanks in advance!


Great question! REMS or "Risk Evaluation and Mitigation Strategies" is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns, intended to help ensure the benefits of the medication outweigh its risks.  There are many drugs that require REMS currently.  We will highlight the REMS program in the Drug of the Week next week.

Thanks for asking!

Jill Kolesar and Lee Vermeulen