Results 51 to 60 of about 6,056 (173)

Improving Drug Safety: The Importance of Postmarking Drug Surveillance [PDF]

, 2004
Improved postmarketing surveillance system may reduce the number of adverse reactions to prescription drugs that under the current system continue to rise as the number of prescriptions written in the U.S ...
James Nyberg, Robert N. Butler
core  

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
core   +4 more sources

The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine

Clinical Pharmacology &Therapeutics, Volume 119, Issue 2, Page 318-321, February 2026.
In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user‐friendly dashboards. This has led to a large increase in low‐quality, poorly reported research using adverse event reporting databases (e.g., FDA’s Adverse Event Reporting System ...
Charles Khouri, Alex Hlavaty, Michele Fusaroli, Nitin Joshi, Francesco Salvo, Andrew Bate, Antoine Pariente, Emanuel Raschi   +7 more
wiley   +1 more source

Current Trends in Duchenne Muscular Dystrophy Research and Therapy: 3D Cardiac Modelling

Journal of Cachexia, Sarcopenia and Muscle, Volume 17, Issue 1, February 2026.
ABSTRACT Duchenne muscular dystrophy (DMD), caused by dystrophin deficiency, presents a multifaceted challenge that affects both skeletal muscle function and cardiomyocyte homeostasis, causing progressive degeneration and life‐threatening cardiac complications by adolescence.
Marta Przymuszała, Marta Białobrzeska, Józef Dulak, Urszula Florczyk‐Soluch   +3 more
wiley   +1 more source

Multidimensional Assessment of Neurological Adverse Reactions Related to PD‐1 Inhibitors: A Real‐World Pharmacovigilance Study

CNS Neuroscience &Therapeutics, Volume 32, Issue 1, January 2026.
This pharmacovigilance study systematically analyzed PD‐1 inhibitor–associated neurological adverse events using FAERS data from 2014 to 2024. Central nervous system toxicities, including encephalitis and brainstem encephalitis, were most prominent. Older age, female sex, specific cancer types, and combination therapies increased the risk, with most ...
Xiaofeng Hu, Xiaoli Wang, Bufu Tang, Dehuan Zhang, Rongbing Cai, Hui Jiang, Yaling Lin, Yiheng Song, Yiou Wang, Hairuo Huang, Dandan Guo, Xubin Sun, Hongjie Fan   +12 more
wiley   +1 more source

MDDC: An R and Python package for adverse event identification in pharmacovigilance data

Scientific Reports
The safety of medical products continues to be a significant health concern worldwide. Spontaneous reporting systems (SRS) and pharmacovigilance databases are essential tools for postmarketing surveillance of medical products.
Anran Liu, Raktim Mukhopadhyay, Marianthi Markatou   +2 more
doaj   +1 more source

Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

International Journal of Dermatology, Volume 65, Issue 1, Page 108-118, January 2026.
ABSTRACT Background The United States Food and Drug Administration (FDA) approved oral finasteride for androgenetic alopecia. In 2022, approximately 2.6 million U.S. men used it for hair loss and prostate conditions. Post‐finasteride syndrome (PFS), proposed in 2012, involves persistent sexual and neuropsychiatric adverse events (AEs) after cessation ...
Aditya K. Gupta, Mesbah Talukder, Sharon A. Keene, Mary A. Bamimore   +3 more
wiley   +1 more source

The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation [PDF]

, 2018
When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions, or ...
Naci, Huseyin, Ross, Joseph S., Wallach, Joshua D.   +2 more
core   +1 more source

A Critical Review of the FDA’s Draft Guidance on Artificial Intelligence in Drug and Biological Product Regulation

Journal of Chemistry, Volume 2026, Issue 1, 2026.
Artificial intelligence (AI) has reached a critical juncture in its integration with healthcare and pharmaceutical developments. Regulatory agencies worldwide are developing frameworks to guide the responsible implementation of AI‐driven drug development and approval processes. The United States Food and Drug Administration (FDA) released its inaugural
Sarfaraz K. Niazi, Sohini Basu Roy
wiley   +1 more source

LC-Q-TOF-MS driven identification of potential degradation impurities of venetoclax, mechanistic explanation on degradation pathway and establishment of a quantitative analytical assay method

Journal of Analytical Science and Technology, 2020
Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies.
Dhruvisha Pokar, Amit Kumar Sahu, Pinaki Sengupta   +2 more
doaj   +1 more source