The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s risk evaluation and mitigation strategy (REMS) logic model.
FDA described a REMS logic model as a framework recommended by the agency that is a “systematic, structured approach to the design, implementation, and evaluation of a REMS” with a goal of having the applicants’ goals, objectives, and strategies line up with intended outcomes. Examples of a REMS include a communication plan, a package insert for a patient, a medication guide, and technologies associated with packaging and safe disposal for a drug at risk of abuse or overdose. They noted the draft guidance does not focus on the relationship between REMS or risk management and the benefit-risk assessment for a drug, nor does it focus on when the use of a REMS is necessary to determine when the benefits of a drug outweigh its risks…
