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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. As stakeholders begin implementing R3, many questions remain regarding its practical application. By Julie Kim & Deborah L.

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Growing together: How Sound creates a culture of leadership

Sound Physicians

Great patient care starts with great clinician leadership. I am often asked about how Sound builds the next generation of clinical leaders. The expertise and thoughtfulness that our leaders bring to our patients, teams, and, most importantly, our hospital partners is not something that just happens.

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Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

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Working Out – Dan Minter

The Clinical Problem Solvers

This is a peer-nominated group of academic clinicians renowned for their medical knowledge, teaching & communication skills, professionalism, and high-quality patient care. Some specific activities mentioned by the participants included patient-directed reading (e.g., “How do they do it?!!” NEJM , JHM , JGIM ).

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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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Are your patients satisfied?

Physician's Practice

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. If your patients are unhappy with care then they probably won't come back to your practice. June 25, 2025 By Neil Baum, MD Fact checked by Keith A.

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

FDA Law Blog

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

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