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...
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).
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...
The western journal of emergency medicine
Jan 1, 2025
INTRODUCTION: Medical device recalls are important to the practice of emergency medicine, as unsafe devices include many ubiquitous items in emergency care, such as vascular access devices, ventilators, infusion pumps, video laryngoscopes, pulse oxim...
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...
Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing
Jan 1, 2025
The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment...
IMPORTANCE: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication revi...
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...
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.
Over the past 60 years, drug-induced liver injury (DILI) has played a key role in the withdrawal of marketed drugs due to safety concerns. Early prediction of DILI is crucial for developing safer pharmaceuticals, yet current and testing methods are...