新药办公室新药和生物制品申请标准安全表格和图表 – 2026年6月23日

正文内容

News & Events for Human Drugs Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications – 06/23/2026 Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) The goal of this webinar is to provide general audiences information on the standard safety tables and figures integrated guide and Manual of Policies and Procedures (MAPP) for the premarket safety evaluation of new drug and biologic products. Participants will gain knowledge of the presentation and analyses for tables and figures that the Office of New Drugs (OND) considers important for understanding the application including adverse events, subgroups, laboratory, and vital signs analyses. Attendees will also gain a general overview of the Targeted Analysis Guides. Individuals working on premarket safety evaluations Presentation Title: Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications Speaker: B. Nhi Beasley, PharmD. Commander, United States Public Health ServiceAssociate Director Biomedical InformaticsDivision of Biomedical Informatics, Research and Biomarker Development | Office of Drug Evaluation and Science | Office of New Drugs | CDER | FDA Clinical reviewers in pharmaceutical industry and U. S. FDA Regulatory science and regulatory affairs professionals Clinical research coordinators Table and figure format and order of presentation for adverse events and serious adverse events analyses Tables and figures for laboratory analyses The publicly available Targeted Analysis Guides and a general overview of their contents Office of New Drugs Standard Safety Tables and Figures (ST&Fs) public website ST&F Manual of Policies and Procedures