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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. By Julie Kim & Deborah L. No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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Growing together: How Sound creates a culture of leadership

Sound Physicians

It is, by design, built into the ways we educate, train, and support our clinical leadership. Creating an internal pool of leadership potential is one of the best ways to maintain a steady recruitment of clinicians who understand how to run a practice effectively. Enter the associate medical director.

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Working Out – Dan Minter

The Clinical Problem Solvers

From these conversations, they identified four general “themes”: (1) consistent learning efforts, (2) rigorous skills development, (3) developing “habits of the mind,” and (4) seeking out clinically rich working environments. These clinicians recount rigorous efforts directed towards improving their knowledge and clinical skills.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. 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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Two “Unresolvable” Prescribing/Dispensing Red Flags Unfurled

FDA Law Blog

Houck We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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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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