CDER Bioresearch Monitoring (BIMO) Requests for New Drug and Biologic Licensing Applications

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

Presenter

Laurie Muldowney, MD
Deputy Director
Office of Scientific Investigations (OSI)
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)

Abstract

In this webinar, Laurie Muldowney, Deputy Director in the FDA CDER’s Office of Scientific Investigations, introduces the final guidance issued on December 6, 2024, regarding electronic submission requirements for new drug and biologics licensing applications. She explains that the guidance, which becomes mandatory after 24 months, aims to standardize the format of data submitted to support bioresearch monitoring inspections. These inspections assess the reliability of clinical trial data, compliance with FDA regulations, and consistency between submitted data and source documents. Muldowney highlights CDER’s risk-based approach to site selection, supported by a web-based tool that analyzes standardized site-level data to enhance inspection efficiency.