REMS Compliance Program

FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections are prioritized using a risk-based approach.

The agency will take action if issues found during the REMS inspections are not promptly and adequately corrected. Failure to comply with REMS requirements may result in enforcement action such as product seizure, injunction or civil money penalties.

FDA also reviews REMS assessment reports to evaluate compliance with legal and regulatory requirements. The agency takes appropriate regulatory action for noncompliance, which may include warning letters or untitled letters, to address serious safety concerns and mitigate risks to patients.

Additional resources

• REMS@fda
• REMS compliance program guide
• Webinar: Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Webinar: Postmarketing drug safety and inspection readiness

Guidances

• FDA’s application of statutory factors in determining when a REMS is necessary
• Development of a shared system REMS
• REMS assessment: Planning and reporting
• Format and content of REMS
• Medication guides – Distribution requirements and inclusion in REMS  
• REMS: Modifications and revisions
• Providing regulatory submissions in electronic format – Content of the REMS document using Structured Product Labeling
• Use of a drug master file for shared system REMS submissions
• Waivers of the single shared system REMS requirement
• Survey methodologies to assess REMS goals that relate to knowledge
• Policy for certain REMS requirements during the COVID-19 public health emergency