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.
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 certain 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 accessed using the link below.
ST&F Integrated Guide
Clinical reviewers use tables and figures to describe clinical trial safety data submitted in marketing applications. Use of consistent displays of tables and figures is intended to improve the quality and consistence of the display of clinical safety data, not interpretation of these data in OND reviews, and to result in more streamlined and efficient marketing application review. 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 laboratory results. 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 accessed below.
Resources
- DIA Global Pharmacovigilance and Risk Management Strategies Conference 2024: FDA Medical Query Update
- Duke Margolis Public Workshop Page: Advancing Premarket Safety Analytics
- Duke Margolis Public Workshop Video Recording: "Advancing Premarket Safety Analytics FDA Medical Queries"