The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.
On January 24, 2019, FDA published guidance on the planning and reporting of the assessment of risk evaluation and mitigation strategies (REMS) for drugs and biologics. The development of a REMS Assessment Plan including the impact on the selection of metrics and data sources is discussed. Also discussed in the guidance are considerations for assessing REMS impact on patient access to drugs and recommendations on reporting REMS findings to FDA.
Specifically, the guidance covers assessment categories, selecting metrics and sources of assessment data, and thresholds for REMS effectiveness. The guidance does not discuss the design or development of REMS.
Source: FDA
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.