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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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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.). We also need to pick up on when a child is gaining weight rapidly or crossing percentiles so we can intervene earlier.

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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. 4,372 of these (92%) also have a current valid certificate in Internal Medicine.

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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. The following is a summary report of the spring meeting.

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

FDA Law Blog

These guidances focused on the types of scientific publications (journal articles, reference texts, and in 2014, clinical practice guidelines) and necessary accompanying information that firms could proactively provide in a manner that would not, on its own, constitute evidence of a new intended use.

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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. Interpretation of Statutory Criteria Under the Final Guidance.

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

GeriPal

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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