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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

It is, by design, built into the ways we educate, train, and support our clinical leadership. Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Excellent leaders rise to the occasion when opportunities are open and available to them.

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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. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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News & Notes: Spring 2025

ABIM

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

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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to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources). Ask clarifying questions.

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

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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