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  4. Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications - 06/23/2026
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Webcast | Virtual

Event Title
Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications
June 23, 2026

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

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.

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

  • 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

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 Service
Associate Director Biomedical Informatics
Division of Biomedical Informatics, Research and Biomarker Development | Office of Drug Evaluation and Science | Office of New Drugs | CDER | FDA

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