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A Novel Definition of Urinary Tract Infection across a National Primary Care Network [Geriatrics]

Annals of Family Medicine

Objective To develop and validate a novel electronic medical records (EMR)-based UTI case definition that can be applied to elucidate and understand UTI treatment and practice patterns in primary care. Context Misdiagnosis and over-diagnosis of urinary tract infection (UTI) are a leading cause of inappropriate antimicrobial use.

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
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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 recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

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