Virtual | Virtual

Event Title

Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data

June 23, 2026

Date:: June 23, 2026
Time:: 12:00 a.m. ET

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About this Event (Hosted by CDER SBIA)

The goal of this webinar is to provide general audiences information on the development and use of Office of New Drugs (OND) Custom Medical Queries (OCMQs) during premarket safety evaluation. OCMQs are standardized groupings of adverse event terms designed to help identify potential safety issues during review of clinical trial adverse event data and to promote a standardized approach across OND Clinical review divisions. Attendees will gain practical knowledge regarding the 104 available OCMQs, the Narrow, Broad, and Algorithmic categories, and the policies and procedures outlined in Manual of Policies and Procedures (MAPP) 6025.8.

Intended Audience

Individuals working on premarket safety evaluations
Clinical reviewers in pharmaceutical industry and U.S. FDA
Regulatory science and regulatory affairs professionals
Clinical research coordinators
Academic researchers
Clinical data scientists

Topics Covered

OND Custom Medical Queries (OCMQs) Background
OCMQ Manual of Policies and Procedures (MAPP) 6025.8
OCMQ Frequently Asked Questions (FAQs)

Presentation Title

Office of New Drugs (OND) Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data

Speaker

Linda Jeng, MD., PhD.
Associate Director, Biomedical Informatics and Regulatory Review Science (BIRRS)(Acting)
Division of Biomedical Informatics, Research and Biomarker Development
Office of Drug Evaluation and Science | Office of New Drugs
Center for Drug Evaluation and Research (CDER) | FDA

Resources

Event Materials

Title	File Type/Size
Presentation Slides \| Office of New Drugs Custom Medical Queries(OCMQs) for Safety Signal Detection in Clinical Trial Data	pdf (992.92 KB)