Processes and practices applicable to Bioresearch Monitoring (BIMO) inspections (FDA)

24th December 2025

Processes and practices applicable to Bioresearch Monitoring (BIMO) inspections (FDA)

Summary: This FDA guidance explains the key processes and practices used during inspections conducted under the agency’s Bioresearch Monitoring (BIMO) programme, which covers clinical investigators, sponsors, contract research organisations (CROs), IRBs, and other sites involved in FDA-regulated research. The guidance was issued to meet requirements under the Food and Drug Omnibus Reform Act (FDORA) 2022 and aims to improve transparency and consistency in how BIMO inspections are carried out. It outlines what records and information may be requested, best practice for communication before and during inspections, and expectations for how FDA will handle inspection conduct, including interactions with staff and processes for addressing observations. The goal is to support effective oversight while helping organisations prepare for inspections and respond efficiently to FDA requests. 

Link: Processes and practices applicable to Bioresearch Monitoring inspections

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