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Episode 53 – Clinical unknown Dr. Paul Sax – Cough & Rash

The Clinical Problem Solvers

[link] Episode description Dan Minter presents a clinical unknown to Dr. Paul Sax Download CPSolvers App here Dr. Paul Sax Dr. Paul E. Sax is Clinical Director of the Division of Infectious Diseases and the HIV Program at Brigham and Women’s Hospital (BWH), and Professor of Medicine at Harvard Medical School. Rash Radiology

Clinic 52
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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law

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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Episode 54 – Clinical unknown w/ Dr. Paul Sax – Fever and Headache

The Clinical Problem Solvers

[link] Episode description Emma Levine presents a clinical unknown to Dr. Paul Sax Download CPSolvers App here Dr. Paul Sax Dr. Paul E. Sax is Clinical Director of the Division of Infectious Diseases and the HIV Program at Brigham and Women’s Hospital (BWH), and Professor of Medicine at Harvard Medical School.

Clinic 52
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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. Dedicated to supporting medical directors in their leadership and team management, they support talent reviews, facilitate engagement surveys, offer certified coaching, and create personal development tools.

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Migraine headaches: diagnostic and treatment tips

Common Sense Family Doctor

Clinical practice guidelines on the management of episodic migraine headache, including the 2023 US Veterans Affairs/Department of Defense guideline , preferentially recommend triptans for most patients.

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

FDA Law

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.

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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