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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. He emphasized ABIM’s focus on patient-centered standards and promoting high-quality care, as well as ABIM’s commitment to ensuring a diverse governance that reflects the physician and patient population. Community Practice in ABIM Governance* Erica N.

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Rheumatology Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N.

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Infectious Disease Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. Community Practice in ABIM Governance* Erica N.