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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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Growing together: How Sound creates a culture of leadership

Sound Physicians

Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. This unique leadership role provides another layer of leadership to support the medical director and even act as chief in their absence. Enter the associate medical director.

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

FDA Law Blog

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. Provide both completed and planned actions and related timelines.

Provider 111
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Rheumatology Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit. Dr. Mansoor stressed that fellows train with specialist support that does not truly reflect community 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. He has written ten books on practice management and the business of medicine.

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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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You don’t need to order comprehensive viral panels for most patients

PEMBlog

This is a blog post 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. for bronchiolitis and 1.5%