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.