Risk Evaluation and Mitigation Strategy (REMS)

Glossary

Risk management plans required by the Food and Drug Administration (FDA) to ensure that the benefits of certain prescription drugs outweigh the risks. Under the FDA Amendments Act of 2007, the agency may require that sponsors of certain new drug applications, abbreviated new drug applications, and biologics license applications develop and implement an FDA-approved risk evaluation and mitigation strategy (REMS). (21 U.S.C § 355–1.)

A REMS includes one or more of the following:

Medication guide. This FDA-approved patient labeling helps patients understand risks, decide whether to take the drug, and follow directions deemed crucial for effectiveness.
Communication plan. This is the sponsor's plan to inform healthcare providers of the drug's risks and REMS requirements.
Elements to Assure Safe Use (ETASU). ETASU are medical interventions or other requirements for healthcare professionals, including:
- training or experience for prescribers;
- certifying dispensers;
- restricting use to healthcare settings;
- documenting safe-use conditions before dispensing; and
- monitoring or enrolling patients in a registry.
Implementation system. This includes reasonable steps the sponsor takes to monitor REMS compliance.

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