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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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Expert Panel Unveils Preanesthesia Cannabis Use Assessment Tool

Physician's Weekly

An expert panel unveiled a preoperative cannabis use assessment tool to aid in planning informed, individualized anesthesia and analgesia patient care. An expert panel has created a preoperative cannabis use assessment tool to aid healthcare professionals in planning informed, individualized anesthesia and analgesia care for patients.

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Hypertensive Crisis with Dr. Travis Huffman

Louisville Lectures

Hypertensive Emergency and management of both Markedly elevated BP and HTN Emergency/Crisis. For more information, see our citation page. Travis Huffman is a PGY 2 resident in the University of Louisville Internal Medicine Residency Program. Disclaimers ©2015 LouisvilleLectures.org

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

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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. Ask clarifying questions.

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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 Blog

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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Eric 11:57 In, let’s say, my clinic. Eric 08:05 Yeah.

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