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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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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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4 Ways Temporary Medical Staff Maintain Patient Care

Barton Associates

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Adapt quickly to new processes, electronic health record (EHR) systems, and more.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

Provider 111
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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.”

Medical 111
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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Asthma 52
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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. About Neil Baum, M.D.