The Development and Use of Office of New Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data

https://link.springer.com/article/10.1007/s40264-025-01582-1?utm_medium=email&utm_source=govdelivery FDA Publishes Manuscript on Office of New Drugs Custom Medical Queries for Safety Analysis of Clinical Trial Data The U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) has published a manuscript, “The Development and Use of Office of New Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data,” in the Drug Safety journal. OND Custom Medical Queries (OCMQs) are intended to capture clinically meaningful groupings (i.e., safety signals) in premarketing data. OCMQs have become an important component of premarket drug safety evaluations, as they have improved FDA’s ability to detect safety signals and distinguish and quantify adverse reactions in clinical trial data. The use of OCMQs promotes a consistent safety signal detection strategy across OND divisions. This article provides an overview of the development and use of OCMQs in evaluating premarket drug safety. More information about OCMQs is available here. https://www.fda.gov/drugs/development-resources/office-new-drugs-custom-medical-queries-ocmqs?utm_medium=email&utm_source=govdelivery