Pharmacovigilance

Risk Evaluation and Mitigation Strategy(REMS)

A drug safety program required by FDA for certain medications with serious safety concerns to ensure benefits outweigh risks.

Usage Examples

The opioid received a REMS with ETASU requiring prescriber certification.
The REMS assessment showed improved patient outcomes.
FDA requested modifications to the REMS communication plan.

What is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a safety strategy required by FDA to manage known or potential serious risks associated with a drug product. REMS go beyond the standard labeling to ensure that benefits outweigh risks.

REMS may include Medication Guides, Communication Plans, Elements to Assure Safe Use (ETASU), and Implementation Systems. ETASU may require prescriber training, patient enrollment, pharmacy certification, or restricted dispensing.

FDA can require REMS at approval or post-marketing if new safety information emerges. REMS assessments must be submitted periodically to evaluate effectiveness.

Regulatory Context

This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 314, FDAAA.

FDAEMAWHO

When This Matters

The opioid received a REMS with ETASU requiring prescriber certification.
The REMS assessment showed improved patient outcomes.
FDA requested modifications to the REMS communication plan.

Common Mistakes

Treating safety signal reviews as periodic instead of continuous.
Not linking new enforcement letters to internal CAPA and labeling workflows.
Using static templates for dynamic benefit-risk communication updates.

Related Regulations

21 CFR 314FDAAA

Frequently Asked Questions

FDA requires REMS for drugs with serious safety concerns where the standard labeling alone is not sufficient to ensure safe use. Examples include opioids, clozapine, and isotretinoin.

Elements to Assure Safe Use (ETASU) are specific requirements beyond labeling, such as prescriber/pharmacy certification, patient enrollment, or restricted distribution systems.