Definition

A US FDA-required drug safety program to ensure benefits outweigh risks, which may include medication guides, communication plans, or elements to assure safe use.

Example

The REMS for an opioid includes: prescriber certification, patient counseling requirements, pharmacy enrollment, and dispensing restrictions to mitigate misuse risk.

Regulatory source

FDA, FDAAA 2007

Common mistakes

Treating REMS as a one-time submission rather than an ongoing program requiring monitoring and assessment.

Inspector question

Describe your REMS program. How do you assess its effectiveness?

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