Assessing Exposure to Recently Approved Medications to Inform Feasibility for Signal Identification Analyses in the FDA’s Sentinel System

At the time of approval, new molecular entity drugs and therapeutic biologics (i.e., new medications) have limited safety data. The U.S. Food and Drug Administration (FDA) primarily depends on spontaneous reporting systems and other passive information sources for identifying new safety signals after approval. Recently, the FDA began implementing an active surveillance approach by applying tree-based scan statistics (TBSS) to the Sentinel Distributed Database (SDD) to enhance postmarketing safety surveillance activities. However, the effectiveness of TBSS relies heavily on the size of the exposed population.

This poster identifies and evaluates medications approved by the FDA from 2017-2021 with adequate population exposure for effective post-marketing surveillance using TBSS. It was presented at the 2024 ISPE Annual Meeting.