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On June 3rd, 2026, the International Council of Harmonisation’s final ICH Guideline for Good Clinical Practice (GCP) E6(R3) Annex 2 was adopted in step 4 of the ICH formal procedure. A reminder of ICH’s standardized five-step formal procedure of developing, adopting, and implementing of guidelines can be reviewed.
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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”.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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”.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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On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
