The FDA is increasingly asking drug companies to submit, and comply with, a Risk Evaluation and Mitigation Strategy (REMS) as a condition of product approval. REMS is defined by the FDA as a “strategy to manage a known or potential serious risk associated with a drug or biological product.” The components of a REMS program can include:
• Medication guides or communication plans to communicate proper dosing and risks
• Elements to assure safe use or distribution
• Implementation systems to limit the distribution channels, the settings of care or to condition usage based on evidence of safe-use conditions or test results
