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Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.
J Med Syst
January 2025
Advancing a Healthier Wisconsin Endowment, Medical College of Wisconsin, Milwaukee, WI, USA.
Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S.
View Article and Find Full Text PDFHarnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective.
Pharmaceuticals (Basel)
January 2025
College of Pharmacy, University of Illinois, Chicago, IL 60612, USA.
Artificial Intelligence (AI) has the disruptive potential to transform patients' lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI's rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies.
View Article and Find Full Text PDFThe 2024 American Association for Thoracic Surgery expert consensus document: Current standards in donor lung procurement and preservation.
J Thorac Cardiovasc Surg
February 2025
Division of Thoracic Surgery, University of Toronto, Toronto, Ontario, Canada. Electronic address:
Background: Donor lung procurement and preservation is critical for lung transplantation success. Unfortunately, the large variability in techniques impacts organ utilization rates and transplantation outcomes. Compounding this variation, recent developments in cold static preservation and new technological advances with machine perfusion have increased the complexity of the procedure.
View Article and Find Full Text PDFA pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database.
Expert Opin Drug Saf
January 2025
Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Background: Faricimab is predominantly prescribed for conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema related to retinal vein occlusion (RVO-ME). Currently, a notable absence of large-scale, real-world studies focusing on the adverse reactions of faricimab exists.
Methods: This study assesses the side effects of faricimab by analyzing reports of adverse events (AEs) from the FDA's AE Reporting System (FAERS) database.
Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development.
PLoS One
January 2025
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
End-user feedback early in product development is important for optimizing multipurpose prevention technologies for HIV and pregnancy prevention. We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n = 23), and when used for 90 days cyclically or continuously in MTN-044/IPM 053/CCN019 (n = 25). We enrolled healthy, non-pregnant, HIV-negative women aged 18-45 in Pittsburgh, PA and Birmingham, AL (MTN-030 only).
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