AIMC Topic: United States Food and Drug Administration
Clear Filters Showing 11 to 20 of 97 articles
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...
Congress Must Update FDA Regulations for Medical AI.
JAMA health forum
Jul 5, 2024
Trust but Verify: Lessons Learned for the Application of AI to Case-Based Clinical Decision-Making From Postmarketing Drug Safety Assessment at the US Food and Drug Administration.
Journal of medical Internet research
Jun 6, 2024
Adverse drug reactions are a common cause of morbidity in health care. The US Food and Drug Administration (FDA) evaluates individual case safety reports of adverse events (AEs) after submission to the FDA Adverse Event Reporting System as part of it...
Timing Matters: A Machine Learning Method for the Prioritization of Drug-Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure.
Drug safety
Apr 30, 2024
INTRODUCTION: Current drug-drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to false-positive disproportionality signals in spontaneous reporting system (SRS) databases.
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.
The AAPS journal
Apr 8, 2024
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research needs to improve and enhance bioequivalence (BE) approaches for generic drug development. FDA takes ...
AI as a New Frontier in Contrast Media Research: Bridging the Gap Between Contrast Media Reduction, the Contrast-Free Question and New Application Discoveries.
Investigative radiology
Oct 12, 2023
Artificial intelligence (AI) techniques are currently harnessed to revolutionize the domain of medical imaging. This review investigates 3 major AI-driven approaches for contrast agent management: new frontiers in contrast agent dose reduction, the c...
The Coming of Age of AI/ML in Drug Discovery, Development, Clinical Testing, and Manufacturing: The FDA Perspectives.
Drug design, development and therapy
Sep 6, 2023
Artificial intelligence (AI) and machine learning (ML) represent significant advancements in computing, building on technologies that humanity has developed over millions of years-from the abacus to quantum computers. These tools have reached a pivot...
FDA Modernization Act 2.0: An insight from nondeveloping country.
Drug development research
Aug 17, 2023
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new ...
Classifying Free Texts Into Predefined Sections Using AI in Regulatory Documents: A Case Study with Drug Labeling Documents.
Chemical research in toxicology
Jul 24, 2023
The US Food and Drug Administration (FDA) regulatory process often involves several reviewers who focus on sets of information related to their respective areas of review. Accordingly, manufacturers that provide submission packages to regulatory agen...
Don't Miss the Future of Medicine
Join thousands of healthcare professionals staying informed about the latest AI breakthroughs in medicine. Get curated insights delivered to your inbox.
Subscribe NowPopular Topics
- Machine Learning 31964
- Neural Networks, Computer 30201
- Algorithms 27375
- Deep Learning 26880
- Artificial Intelligence 24818
- Robotics 13382
- Image Processing, Computer-Assisted 9730
- Retrospective Studies 9328
- Magnetic Resonance Imaging 6341
- Reproducibility of Results 5670
- Tomography, X-Ray Computed 4863
- Support Vector Machine 4762
- Computational Biology 4328
- Brain 4125
- Computer Simulation 3932
Recent Journals
- Scientific reports 6689
- Sensors (Basel, Switzerland) 4794
- PloS one 4186
- Neural networks : the official journal of the International Neural Network Society 3026
- Computational intelligence and neuroscience 1931
- Computers in biology and medicine 1915
- Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference 1686
- Studies in health technology and informatics 1378
- IEEE journal of biomedical and health informatics 1167
- Journal of chemical information and modeling 1059
- Nature communications 1029
- Computer methods and programs in biomedicine 883
- Bioinformatics (Oxford, England) 872
- Journal of medical Internet research 853
- Briefings in bioinformatics 853