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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. Terminology and Content Standards in Assessment* Dr.

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Q&A: Prioritizing Early Intervention in Pediatric Obesity

Physician's Weekly

The 2023 American Academy of Pediatrics (AAP) Clinical Practice Guidelines has a section that discusses different approaches (eg, virtual visits, including allied providers, thinking about community programs, etc.). How can clinicians improve access to childhood obesity interventions? It really does take a village.

Family 52
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Rheumatology Board Meeting Summary | Spring 2025

ABIM

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 Blog

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 Blog

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. Other medical information.

Clinic 52