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Developing a cost-effective and efficient safety case management solution for data coordinating center projects.
Contemp Clin Trials
January 2025
RTI International Center for Clinical Research, 3040 East Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC 27709-2194, USA. Electronic address:
A centralized safety function can support multiple clinical trials and provide efficient, standardized processes for the management of serious adverse events. From 2017 to 2022, the centralized safety desk used pharmacovigilance software compliant with FDA regulations, including 21 CFR Part 11. This software assisted with processing safety cases for regulated clinical trials, including allowing capture of event data, and provided process flow management, documentation storage, and transmission of safety reports to FDA.
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.
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 to harnessing these technologies to enhance human and animal health by supporting innovative products and methods. Key areas of focus include regulatory adaptation, genomic research, and information technology modernization.
View Article and Find Full Text PDFMenin Inhibitors: New Targeted Therapies for Specific Genetic Subtypes of Difficult-to-Treat Acute Leukemias.
Cancers (Basel)
January 2025
Hematology Unit, S. Eugenio Hospital (ASL Roma 2), 00122 Rome, Italy.
Menin (MEN1) is a well-recognized powerful tumor promoter in acute leukemias (AL) with KMT2A rearrangements (KMT2Ar, also known as MLL) and mutant nucleophosmin 1 (NPM1m) acute myeloid leukemia (AML). MEN1 is essential for sustaining leukemic transformation due to its interaction with wild-type KMT2A and KMT2A fusion proteins, leading to the dysregulation of KMT2A target genes. MEN1 inhibitors (MIs), such as revumenib, ziftomenib, and other active small molecules, represent a promising new class of therapies currently under clinical development.
View Article and Find Full Text PDFInnovative perspectives on metal free contrast agents for MRI: Enhancing imaging efficacy, and AI-driven future diagnostics.
Acta Biomater
January 2025
Institute of Smart Biomedical Materials, School of Materials Science and Engineering, Zhejiang Sci-Tech University, Hangzhou 310018, PR China. Electronic address:
The U.S. Food and Drug Administration (FDA) has issued a boxed warning and mandated additional safety measures for all gadolinium-based contrast agents (GBCAs) used in clinical magnetic resonance imaging (MRI) due to their prolonged retention in the body and associated adverse health effects.
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