The US Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP) to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency.
Although the statute does not specifically describe how companies should conduct their assessments, the agency has released two draft guidances (one on survey methodologies and another on planning and reporting REMS assessments, both from last January) and now, this new MAPP, effective 18 December 2019, for further explanation.
FDA can require a REMS for certain drugs if it determines that one is necessary to ensure that the benefits of the drug outweigh its risks. A REMS may include a medication guide, a patient package insert, a communication plan and/or packaging and disposal requirements. FDA also may require certain elements to assure safe use (ETASU) as part of a REMS.
FDA finalized guidance in May on when a REMS is necessary…