REMS (Risk Evaluation and Mitigation Strategy)
An FDA-required safety program for a drug whose risk needs more than standard labeling to manage.
REMS stands for Risk Evaluation and Mitigation Strategy, an FDA-required program for a drug whose serious risks can't be managed through labeling alone. The FDA has had the authority to require REMS programs since 2007. The simplest version is just a Medication Guide handed to every patient. More involved versions add a formal communication plan to prescribers or, for the highest-risk drugs, Elements to Assure Safe Use, things like prescriber certification, mandatory patient registries, or distribution restricted to specific pharmacies.
A drug carrying a REMS almost always also carries a boxed warning, since both exist for the same underlying reason: the risk is serious enough that the standard PI isn't judged sufficient on its own. For promotional content, a REMS program usually means extra material beyond the core asset, patient counseling documents, certification forms, that also has to clear MLR before use.