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Annex 2 of ICH E6(R3) Reaches Step Four

08/11/2026

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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. 

Annex 2 of ICH E6(R3) Reaches Step Four
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New Draft Guidance – Responding to FDA Form 483s

07/23/2026

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On March 9th, 2026, the US Food and Drug Administration (FDA) released a draft guidance “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection”.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).

New Draft Guidance – Responding to FDA Form 483s
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Update - ISO 14155 Device GCP 2026 and Clinical ...

06/07/2026

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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.

Update - ISO 14155 Device GCP 2026 and Clinical Pathway’s New eLearning & Comparison Tool
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Get Ready for AI Assisted FDA Inspections Part ...

05/26/2026

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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.

Get Ready for AI Assisted FDA Inspections Part 3/3
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Get Ready for AI Assisted FDA Inspections Part ...

04/30/2026

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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.

Get Ready for AI Assisted FDA Inspections Part 2/3

ICH e8r1

FDA Releases Guidance: Overview of ICH E8(R1): General Considerations for Clinical Studies

04/12/2022

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Clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. ICH E8(R1) is intended to address the concerns about the principles of trial design and planning that are needed to ensure an appropriate level of data quality.

Now Available for Purchase: Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

02/22/2022

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ICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.