FDA Publishes REMS Assessment Guidance
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
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
