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BioWorld - Sunday, July 12, 2026
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Home » FDA declines to clarify on-site access restrictions in BiMo final
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FDA declines to clarify on-site access restrictions in BiMo final

Dec. 31, 2025
By Mark McCarty
The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.
Medical technology Regulatory U.S. FDA

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