A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviours and actions that support the safe use of that medication. While all medications have labelling that informs health care stakeholders about medication risks, only a few medications require a REMS. REMS was previously known as RiskMAP
IMDRF is the International Medical Device Regulators Forum. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and to accelerate international medical device regulatory harmonization and convergence.