Which statement best defines a Risk Evaluation and Mitigation Strategy (REMS)?

• A. A general labeling requirement for all medications.
• B. A post-market surveillance program only for devices.
• C. FDA-required special procedures that are used when MedGuides, PPIs, and CMI are not enough
• D. An optional marketing plan for new drugs.

Answer: (C)

REMS are FDA-mandated programs to manage serious safety concerns for certain medications. They are used when the standard information already provided, including MedGuides, Patient Package Inserts, and Consumer Medication Information, isn’t enough to ensure safe use. A REMS involves special procedures required by the FDA—such as restricted access, mandatory training or certification for prescribers and pharmacists, or patient enrollment in a monitoring program—to help ensure that the drug’s benefits outweigh its risks. They apply only to specific drugs or biologics, not to all medications, and they are not optional marketing plans or limited to devices.