Background
Office of New Drugs (OND) Custom Medical Queries (OCMQs), formerly known as FDA Medical Queries (FMQs), are standardized groupings of similar adverse event (AE) terms intended to assist with the identification of potential safety issues during the review of AE safety data. While other AE groupings already exist, (e.g., Standardised MedDRA Queries (SMQs)), OCMQs are clinically meaningful groupings used by OND staff for premarket safety evaluation. The use of OCMQs promotes a consistent safety signal detection strategy across OND Divisions.
Using OCMQs and Algorithmic OCMQs
OCMQs are available to review teams receiving Standard Safety Tables and Figures (ST&Fs) and in available review software.
In addition to the Narrow and Broad components of each OCMQ, some OCMQs contain an Algorithmic component, which uses additional information to identify safety signals such as combinations of adverse event terms instead of a single term, laboratory data, concomitant medications, medical history, or timing information. Each Algorithm includes of a series of criteria, and patients who meet the specified criteria are considered to have met the requirement of the algorithm. For additional information about an Algorithmic OCMQ, see the associated Targeted Analysis Guide on the Standard Safety Tables and Figures (ST&Fs) Figures and Tables page.
OCMQ Manual of Policies and Procedures (MAPP)
The OCMQ Manual of Policies and Procedures (MAPP) and its attachments describe the use of OCMQs during review of new drug applications (NDAs), biologics license applications (BLAs), and supplemental NDAs and BLAs for the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). The OCMQ MAPP can be downloaded using the link below.
Latest OCMQ Version
The current OCMQ version includes terms released in MedDRA v26.0 or earlier. Updated OCMQ versions will be released periodically and reflected on this page. A list of the current OCMQs with their associated terms can be downloaded using the link below.
Resources
Contact Us
ONDBiomedicalinformatics@fda.hhs.gov
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Content current as of:
05/01/2025
