Office of New Drugs Custom Medical Queries (OCMQs)

https://www.fda.gov/drugs/development-resources/office-new-drugs-custom-medical-queries-ocmqs?utm_medium=email&utm_source=govdelivery FDA Releases Version 4.0 of OND Custom Medical Queries The U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) has released version 4.0 of the OND Custom Medical Queries (OCMQs), which includes terms released in MedDRA v27.0 and earlier. Updated OCMQ versions will be released periodically on the Office of New Drugs Custom Medical Queries (OCMQs) webpage, where the latest OCMQ version can be downloaded. OCMQs are intended to capture clinically meaningful groupings (i.e., safety signals) in premarketing safety data. OCMQs have become an important component of premarket drug safety evaluations, as they promote a consistent safety signal detection strategy across OND divisions.