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ICH E6(R3) Progresses into Step Four
01/15/2025
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
New Draft Guidance on Protocol Deviation Management Part 1/2
01/14/2025
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On December 30, 2024, the US Food and Drug Administration (FDA) released the draft guidance for industry titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” to help trial sponsors, investigators, and institutional review boards (IRB) define, identify, and report protocol deviations.
WHO Issues Draft Guidance on Clinical Trials Best Practices
08/01/2023
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The World Health Organization (WHO) issued a draft guidance for best practices for clinical trials in July 2023. It outlines key scientific and ethical considerations for “good controlled” (also known as well-controlled) trials, guidance on strengthening the clinical trial ecosystem, and addressing underrepresented populations.
FDA Announces ICH E6(R3) Open Comment Period
06/14/2023
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The U.S. Food and Drug Administration (FDA) announced that the ICH E6(R3) Good Clinical Practice draft guidance is available for comments. This draft includes the GCP Principles and Annex 1, and the ICH Working Group is updating Annex 2.