FDA Issues Safety Tables & Figures Framework for NDA/BLA Reviews

Regulatory affairs leads preparing NDA and BLA submissions now have a defined structural target: FDA's Center for Drug Evaluation and Research (CDER) has formalized its Standard Safety Tables and Figures (ST&F) initiative, establishing a standardized framework that clinical reviewers within the Office of New Drugs (OND) will use to assess safety data packages across all divisions. Sponsors whose data packages do not align with these display conventions face the practical risk of extended review cycles as CDER staff reconstruct outputs to match the framework.

The ST&F system comprises two components. The Integrated Guide (IG) sets a baseline standard for safety analytic tables and figures, covering the consistent display of clinical trial safety data submitted in marketing applications. Alongside it, Targeted Analysis Guides (TAGs) are available on request when reviewers need deeper exploration of specific adverse events or laboratory imbalances. Two TAGs are currently published: a Kidney Injury TAG and a Muscle Injury TAG, each providing therapeutic area-specific displays designed to support signal detection and analysis.

The governing ST&F Manual of Policies and Procedures (MAPP) formalizes how these tools are applied during review of NDAs, BLAs, and certain supplemental applications. The MAPP and its referenced documents are now publicly accessible, giving regulatory teams a direct line of sight into the display standards CDER reviewers will apply. For submission strategists, this is an operational input, not a background document: aligning safety data packages to the IG before submission reduces the reconstruction burden on the review team and positions the application for a more efficient assessment cycle.

The ST&F Working Group within OND developed the framework with two stated objectives: establish a standard set of safety analytic outputs, and create an integrated guide to support reviewer use of those outputs during safety data review. The initiative does not alter the interpretation of safety data; it standardizes the display layer, which is where inconsistency has historically added friction to cross-division reviews.

Supporting resources include an on-demand webinar on ST&Fs for new drug and biologic applications, materials from the DIA Global Pharmacovigilance and Risk Management Strategies Conference 2024, and recordings from the Duke Margolis Public Workshop on advancing premarket safety analytics. Teams with submission-specific questions can contact the OND Biomedical Informatics group directly at [email protected].

As additional TAGs are completed and the MAPP matures through application, the scope of standardized display requirements is likely to expand beyond the two currently published therapeutic area guides.

Source: FDA CDER via FDA.gov Drugs RSS Feed, 2 September 2026.