Standard Safety Tables and Figures (ST&Fs)

Background

The Standard Safety Tables and Figures (ST&F) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions. Standards alignment has been addressed by taking into consideration best practices from multiple sources, including major medical journals, prior FDA reviews, and other publications.

ST&F Manual of Policies and Procedures (MAPP)

This Manual of Policies and Procedures (MAPP) and its referenced documents describe the use of the ST&Fs, which are composed of the Integrated Guide (IG) and Targeted Analysis Guides (TAGs), during review of new drug applications (NDAs), biologics license applications (BLAs), and supplemental NDAs and BLAs for the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). The ST&F MAPP can be downloaded using the link below.

Download the ST&F MAPP

ST&F Integrated Guide

Clinical reviewers use tables and figures to describe and interpret clinical trial safety data submitted in marketing applications. Use of consistent displays of tables and figures can result in more streamlined and efficient marketing application review. To foster consistency in safety review and display of clinical data during FDA review of marketing applications, the FDA OND ST&F Working Group developed the ST&Fs (IG and TAGs) with the following goals: (1) establish a standard set of safety analytic tables and figures; and (2) create an integrated guide containing associated instructions to support clinical reviewers in their use of the ST&F outputs during safety data review.

Download the ST&F Integrated Guide

ST&F Targeted Analyses Guides (TAGs)

TAGs are available by request when the clinical reviewers need to further explore specific adverse events (AEs) or imbalances in lab analyses. These Guides include therapeutic area-specific tables and figures that provide more in-depth analyses to support detection and analysis of potential safety signals. Current completed TAG(s) can be downloaded below.