FDA Law Blog

FEBRUARY 27, 2025

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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ABIM

JUNE 12, 2025

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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ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. He suggested that ABIM work with ACR in the future to publish information about practicing rheumatologists to make it easier for patients to seek rheumatology care from certified physicians in their region. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

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FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). While the information in the SIUU Guidance is a welcome departure from FDA’s more restrictive approaches under GRP, it may not go far enough.

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FDA Law Blog

OCTOBER 10, 2022

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. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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ABIM

JUNE 4, 2025

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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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. They discussed an interest in its ability to collect data specific to practice areas like HIV and geographic areas—like practice ZIP codes—to better understand workforce needs and patterns. Community Practice in ABIM Governance* Erica N.

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