AIMC Topic: United States Food and Drug Administration
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Assessment of drug induced hyperuricemia and gout risk using the FDA adverse event reporting system.
Scientific reports
Jul 2, 2025
Hyperuricemia, the key pathological basis of gout, is increasingly prevalent worldwide. While lifestyle factors contribute, various medications also play a role. However, their specific risks and mechanisms remain inadequately studied. Disproportiona...
Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.
JAMA network open
Apr 1, 2025
IMPORTANCE: The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.
AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.
The AAPS journal
Feb 20, 2025
This paper explores a novel approach using generative AI to enhance drug marketing strategies in the US pharmaceutical sector. By leveraging an official dataset sourced from the US government, the AI generates Python code to analyze the time interval...
Reimbursement and Regulatory Landscape for Artificial Intelligence in Medical Technology.
Gastrointestinal endoscopy clinics of North America
Jan 16, 2025
Integration of artificial intelligence (AI) into medical devices and services promises significant improvements in the diagnosis and treatment of disease. This article reviews current payment pathways for AI medical technology and the regulatory issu...
Artificial intelligence and machine learning in veterinary medicine: a regulatory perspective on current initiatives and future prospects.
American journal of veterinary research
Jan 16, 2025
The US FDA's Center for Veterinary Medicine (CVM) is advancing its leadership in veterinary science by integrating AI and machine learning (ML) into its regulatory framework and scientific initiatives. This paper explores the CVM's strategic approach...
FDA-reviewed artificial intelligence-enabled products applicable to emergency medicine.
The American journal of emergency medicine
Dec 25, 2024
OBJECTIVE: To identify and assess artificial intelligence (AI)-enabled products reviewed by the U.S. Food and Drug Administration (FDA) that are potentially applicable to emergency medicine (EM).
Evaluating a generative artificial intelligence accuracy in providing medication instructions from smartphone images.
Journal of the American Pharmacists Association : JAPhA
Nov 6, 2024
BACKGROUND: The Food and Drug Administration mandates patient labeling materials like the Medication Guide (MG) and Instructions for Use (IFU) to support appropriate medication use. However, challenges such as low health literacy and difficulties nav...
A Machine Learning Method for Allocating Scarce COVID-19 Monoclonal Antibodies.
JAMA health forum
Sep 6, 2024
IMPORTANCE: During the COVID-19 pandemic, the effective distribution of limited treatments became a crucial policy goal. Yet, limited research exists using electronic health record data and machine learning techniques, such as policy learning trees (...
Antibodies, Viral
Humans
Health Policy
SARS-CoV-2
Antibodies, Monoclonal
Machine Learning
Retrospective Studies
Hospitalization
Random Forest
COVID-19
Electronic Health Records
Health Care Rationing
Aged
United States Food and Drug Administration
Young Adult
Female
Middle Aged
Emergency Use Authorization
COVID-19 Drug Treatment
Adult
Severity of Illness Index
Male
Adolescent
Enhancing Postmarketing Surveillance of Medical Products With Large Language Models.
JAMA network open
Aug 1, 2024
IMPORTANCE: The Sentinel System is a key component of the US Food and Drug Administration (FDA) postmarketing safety surveillance commitment and uses clinical health care data to conduct analyses to inform drug labeling and safety communications, FDA...
Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.
Drug safety
Jul 31, 2024
INTRODUCTION: The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse ev...
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