新药办公室定制医学查询（OCMQ）用于临床试验数据中的安全信号检测 – 2026年6月23日
.gov 表示它是官方网站。联邦政府网站通常以 .gov 或 .mil 结尾。在分享敏感信息之前，请确保您访问的是联邦政府网站。该网站是安全的。
正文内容
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.
常见问题
这篇文章和哪些产品相关？
目前没有匹配到足够强相关的商品，补充正文或新增产品后会自动重新关联。
阅读《新药办公室定制医学查询（OCMQ）用于临床试验数据中的安全信号检测 - 2026年6月23日》后，如何查看对应药品？
点击文章下方的相关商品卡片，即可查看商品规格、价格、说明和评价。
本文内容可以替代医生或药师建议吗？
不能。本文只提供一般药品信息和健康教育，具体用药应遵循医生处方和药师指导。
