Standardized Format for Electronic Submission of NDA and BLA Content for BIMO Inspections for CDER Submissions

Back to: FDA CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications

Presenter

Stephanie Coquia, MD
Senior Physician
Division of Clinical Compliance Evaluation
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

Abstract

In this webinar, Dr. Stephanie Coquia, a senior physician in CDER’s Office of Scientific Investigations, outlines the final FDA guidance on standardized electronic submissions to support bioresearch monitoring (BIMO) inspections for NDAs, BLAs, and relevant supplements. Effective December 2026, this binding guidance mandates submission of specific data formats to enable efficient inspection planning and site selection. Dr. Coquia details the three required components: clinical study-level tables, subject-level data line listings, and the Summary Level Clinical Site Dataset (ClinSite Dataset). She emphasizes the use of the Bioresearch Monitoring Technical Conformance Guide (TCG) for formatting, which complements the guidance and is updated more frequently. While the data content aligns with existing regulatory requirements, the format standardization enhances inspection readiness and ensures accurate, timely assessments of trial data integrity and regulatory compliance.