สำนักงานสอบถามข้อมูลทางการแพทย์เฉพาะบุคคลสำหรับยาใหม่ (OCMQ) เพื่อตรวจจับสัญญาณความปลอดภัยในข้อมูลการทดลองทางคลินิก – 23 มิถุนายน 2569

เนื้อหาบทความฉบับเต็ม

News & Events for Human Drugs Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data – 06/23/2026 Visit CDER Small Business and Industry Assistance Page 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. Office of New Drugs (OND) Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data Linda Jeng, MD. , PhD. Associate Director, Biomedical Informatics and Regulatory Review Science (BIRRS)(Acting)Division of Biomedical Informatics, Research and Biomarker DevelopmentOffice of Drug Evaluation and Science | Office of New Drugs Center for Drug Evaluation and Research (CDER) | FDA Individuals working on premarket safety evaluations Clinical reviewers in pharmaceutical industry and U. S. FDA Regulatory science and regulatory affairs professionals Clinical research coordinators OND Custom Medical Queries (OCMQs) Background OCMQ Manual of Policies and Procedures (MAPP) 6025.8 OCMQ Frequently Asked Questions (FAQs) Office of New Drugs Custom Medical Queries (OCMQs) public website OCMQ Manual of Policies and Procedures (MAPP) Proestel S, Popat V, Unger EF, Jeng LJB. The Development and Use of Office of New Drugs Custom Medical Queries for Safety Analyses of Clinical Trial Data. Drug Saf. 2025 Dec;

48(12): 1331-1337. doi: 10.1007/s40264-025-01582-1. Epub 2025 Sep 15. PMID: 40952627; PMCID: PMC12605540.