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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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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.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N.

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

FDA Law

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Rheumatology Board Meeting Summary | Spring 2025

ABIM

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope.

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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

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

I don’t have access to change the levers of government. And either of those could be given to the patient or an informant. And this is, of course, an old and foundational idea about clinical practice. Eric 19:56 Okay, but I’m a primary care provider. Ana chodos, what should I be? Who should I be screening for?

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