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

FDA Law Blog

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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Outcomes of Guidelines from Health Technology Assessment Organizations: A Systematic Mixed Studies Review [Systematic review, meta-analysis, or scoping review]

Annals of Family Medicine

HTA organizations are generally funded by governments, they guide health care professionals and decision/policy-makers, and they publish knowledge translation products such as guidelines. learning), the use of guideline-based information in clinical practice, and subsequent patient health outcomes. Health organization outcomes.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

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

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. Dave suggested contacting physicians who participated in the ACR Convergence Knowledge Bowl as well.

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

FDA Law Blog

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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Episode 120: Antiracism in Medicine Series Episode 1 – Racism, Police Violence, and Health

The Clinical Problem Solvers

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R.

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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 Blog

FDA interprets “other medical information” to include items such as “peer-reviewed clinical studies, clinical practice guidelines, and information that is similarly independently verified and validated as accurate, reliable, not omitting material information, and supported by evidence.”

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