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Get Ready for AI Assisted FDA Inspections Part ...

04/07/2026

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On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of their Artificial Intelligence (AI) Tool: Elsa. AI has been seen in many parts of the clinical research ecosystem in recent years such as trial and protocol design, participant recruitment, and safety monitoring, all of which have the potential to enhance trial efficiency and safety.

Get Ready for AI Assisted FDA Inspections Part 1/3
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FDA releases Final Guidance for BIMO Inspection ...

03/23/2026

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On December 19th, 2025, the US Food and Drug Administration released the finalized guidance for industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections. The guidance details the processes and practices of Bioresearch Monitoring Program (BIMO) inspections of FDA-regulated establishments NOT specified in existing FDA guides or manuals.

FDA releases Final Guidance for BIMO Inspection Program Processes and Practices Not Found in Current Industry Guides or Manuals
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FDA Releases Final Guidance on ICH E6(R3)

02/03/2026

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On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.

FDA Releases Final Guidance on ICH E6(R3)
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Finalized Guidance for Industry: Investigator ...

01/08/2026

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On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting
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EU Commission Releases Draft Annex 11: ...

12/02/2025

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On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.

EU Commission Releases Draft Annex 11: Computerised Systems

Sites and Audits

03/08/2015

Laurie Meehan's post to the Quality Systems for Clinical Research Sites LinkedIn group reminds me that it can be confusing for sites how to manage the various types of site audits that occur. Understanding the relationship of an auditor to a research site is so important.