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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”. The guidance is intended to assist drug manufacturers of FDA regulated drugs or combination products who choose to respond to an FDA Form 483 Inspectional Observations (483).
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In March 2026, the International Organization for Standardization (ISO) published the fourth edition of ISO 14155:2026, replacing the previous edition from 2020. This is the medical device global reference for GCP conduct that many regulatory authorities recognize. Clinical Pathways offers an ISO 14155 Comparison Tool to support you to do an impact analysis and plan updates to SOPs, templates and tools for your trials.
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The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) collaborated with the European Medicines Agency (EMA) to develop 10 Guiding Principles of Good AI Practice in Drug Development. They are intended to be a foundational basis for developing good practices with AI, addressing the unique nature of AI, as well as cultivating its future growth.
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In addition to the launch of Elsa, in a press announcement on December 1, 2025, the FDA broadcasted the deployment of Agentic AI capabilities for their employees. Agentic AI is unique from LLM AI due to its capability to plan, reason, and execute multi-step actions in order to achieve a specific goal. This means it can be used to assist with more complex tasks.
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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.
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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.
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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.
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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.
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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.
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In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.
