Dec 19, 2025 · FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA …

In summary, the BIMO program plays a critical role in ensuring compliance with FDA regulations and the validity of clinical trial data. A well-prepared BIMO data package can expedite regulatory review …

Jan 3, 2026 · Learn the basics of FDA's BIMO inspections, what to expect, and how to ensure complete BIMO inspection readiness in 2026.

Something magical is happening… Puffy’s light is fading, and BIMO with his friends starts a secret rescue mission 🌈 They search for joy, catch sunbeams, find shiny sparkles, laugh together ...

Aug 4, 2022 · FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the …

Nov 6, 2024 · The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable.

These items are included in the background materials provided to the Office of Regulatory Affairs for BIMO inspections; it is important to provide all versions of these documents so that the...

May 20, 2025 · Bioresearch Monitoring Program (BIMO) Compliance Programs Compliance Program Manual

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring ...

May 28, 2024 · FDA’s BIMO program is a comprehensive portfolio of programs designed to assess and monitor all aspects of the conduct and reporting of FDA-regulated research as well as certain …