jueves, 2 de julio de 2026

Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data June 23, 2026

SBIA invites you to view our On-Demand webinar, Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data. At the end of this presentation, participants will understand the development and use of OCMQs during premarket safety evaluation to standardize groupings of adverse event terms, help identify potential safety issues during review of clinical trial adverse event data, and 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 MAPP 6025.8. https://www.fda.gov/drugs/news-events-human-drugs/office-new-drugs-custom-medical-queries-ocmqs-safety-signal-detection-clinical-trial-data-06232026?utm_medium=email&utm_source=govdelivery

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