FDA webinar outlines new Standard Safety Tables and Figures MAP to standardize safety-data displays

Nee Beesley, associate director for biomedical informatics with the FDA's Center for Drug Evaluation and Research (CDER) Office of New Drugs, outlined the Office of New Drugs' Standard Safety Tables and Figures (STNF) Manual of Policies and Procedures during a CDER Small Business and Industry Assistance webinar. The STNF MAP has been effective since June 2025 and the Integrated Guide (IG) and two Targeted Analysis Guides (TAGs) for muscle and kidney injury were released with that version.

The STNF is designed to improve consistency and efficiency in premarket clinical safety reviews by providing a standardized framework for tables and figures used in clinical reviews, Beesley said. "The purpose of the STNF MAP is to describe OND good review practices for the standard safety tables and figures," she said, noting the IG currently contains 60 tables and 22 figures and CDER has presented the IG at more than a dozen public events reaching over 5,000 attendees.

The MAP applies to new drug applications (NDAs), biologics license applications (BLAs), efficacy supplements and, where clinical-trial safety data are submitted, certain over-the-counter monograph order requests. Beesley emphasized that STNF displays are example analyses and should be customized for specific study designs and review needs: "The example tables and figures included in this document are designed to reflect the data values that were provided in a data submission and do not reflect a specific policy or regulatory advice."

Beesley summarized how STNF packages are produced and evaluated. The clinical data scientist generates the STNF package after an initial planning meeting between the CDS and the cross-disciplinary review team (clinical, statistical and ADBMI). The OND clinical review team, together with the office of biostatistics and ADBMI, evaluates data quality and decides which tables and figures to incorporate into the clinical review. Teams may request targeted analyses for potential safety signals as needed.

The STNF divides analyses into three tiers: core (routine analyses generated in every STNF package, such as trial summaries, demographics, disposition and adverse-event summaries), expanded (drill-down analyses) and optional (subject-level listings and alternative displays requested by the clinical team). The guidance also includes formatting principles for tables and figures (for example, treatment-column order, 10-point Arial font, footnotes that cite data sources and definitions, and consistent color conventions for drug versus control in figures).

Beesley described the TAGs as therapeutic-area specific guides that provide more in-depth analyses; the kidney injury TAG consolidates screening analyses and adds medically important outcome analyses, action-taken-with-study-drug metrics and time-to-event and subject-level analyses.

On specific policy points, Beesley said sponsors are not required to submit safety tables and figures in the exact STNF format. "Submission of safety analysis following the exact format in the STNF is not required for marketing applications," she said, adding that sponsors generally should seek alignment with FDA on safety-analysis approach before submission (often via a type C meeting).

She highlighted changes to how causality is handled in STNF AE tables: "AE relatedness to drug, as assessed by the investigator, has been removed from the STNF AE tables," Beesley said, explaining that limited premarket data can limit the ability to ascertain drug relatedness. She also noted that STNF defaults to U.S. conventional laboratory units for FDA review and that unit selection is out of scope for the STNF guidance (sponsors should consult the technical conformance guide for electronic submissions).

Regarding laboratory data inclusion, Beesley said both scheduled and unscheduled laboratory measurements should be considered in safety evaluations but that methods for handling local-laboratory measures and unscheduled visits are out of STNF scope and should be addressed in the trial's statistical analysis plan. She added that the current STNF abnormality criteria reflect adults only and CDER is working to incorporate pediatric laboratory and vital-sign criteria in future updates.

Beesley closed by reiterating that the STNF MAP promotes transparency and consistency in OND review practices, thanked the reviewers who contributed to the documents and directed attendees to the CDER SBIA webpage for links and subscription options for future updates. "The views and opinions expressed in this presentation are mine and do not represent official policy or position of the FDA," she said.